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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K943097
Device Name CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM
Applicant
Global Medical Technologies, Inc.
17 Henry Ave.
Park Ridge,  NJ  07656
Applicant Contact ARRON MEI
Correspondent
Global Medical Technologies, Inc.
17 Henry Ave.
Park Ridge,  NJ  07656
Correspondent Contact ARRON MEI
Regulation Number880.5550
Classification Product Code
FNM  
Date Received06/28/1994
Decision Date 12/23/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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