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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 K900131
Device Name BIO FLOTE(R)
Applicant
Bio Clinic Co.
P.O. Box 1528
10670 Acacia St.
Rancho Cucamonga,  CA  91730
Applicant Contact GILROY, PHD
Correspondent
Bio Clinic Co.
P.O. Box 1528
10670 Acacia St.
Rancho Cucamonga,  CA  91730
Correspondent Contact GILROY, PHD
Regulation Number880.5550
Classification Product Code
FNM  
Date Received01/10/1990
Decision Date 02/16/1990
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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