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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 K883256
Device Name BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM
Applicant
Bio Clinic Co.
Attorney At Law
2085 Rustin Ave.
Riverside,  CA  92507
Applicant Contact STANLEY E FRY
Correspondent
Bio Clinic Co.
Attorney At Law
2085 Rustin Ave.
Riverside,  CA  92507
Correspondent Contact STANLEY E FRY
Regulation Number880.5550
Classification Product Code
FNM  
Date Received08/02/1988
Decision Date 10/31/1988
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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