MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT

File: 970107_sep96_decls14_0010.txt
Page: 0010
Total Pages: 11

Subject: MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR DEPLOYMENT     

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: MEDICAL PRODUCTS UNDER FDA REGULATIONS                                                          

Document Number:     930001

Folder Seq  #:     930000











         DEVICE PRODUCTS:


         1. Field Medical oxygen Generating and Distribution System.

            a.  510(k) # K903411, sponsored by Guild Associates, Inc.

            b.  Manufacturer: Guild Associates, Inc.

            C.  Indication: Produce medical grade oxygen.

            d.  operation Desert Shield status: not required immediately.

            e.  Projected Production Availability: five prototype exist
         and are on call for shipment to Saudi Arabia.

            f.  Point of contact: Major Vreuls, 301-663-7571


         2. Litter, Folding Rigid Pole, Decontaminable.

            a. 510(k)    K901760, sponsored by the US Army Medical
         Materiel Development Activity.

            b. Manufacturer: Arizona Industries for the Blind.

            C. Indication: To evacuate and decontaminate chemical
         casualties.

            d. Operation Desert shield status: required immediately.

            e. Production Availability: Initial production of 720 was
         completed in June l@90, and an additional 800 litters are
         currently being procured.

            f. Point of contact: CPT Splitstoser, 301-663-7418

Document 11 f:/Week-36/BX003201/MEDICAL PRODUCTS UNDER FDA REGULATIONS/medical prod under fda reg required consider for:01029715471415
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = MEDICAL PRODUCTS UNDER FDA REGULATIONS
Folder Seq # = 930000
Subject = MEDICAL PROD UNDER FDA REG REQUIRED CONSIDER FOR
Document Seq # = 930001
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 02-JAN-1997