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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K882229
Device Name AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS
Applicant
Biologics Intl., Inc.
P.O. Box 307
Indian Rocks Beach,  FL  34635
Applicant Contact MARK A HAGOPIAN
Correspondent
Biologics Intl., Inc.
P.O. Box 307
Indian Rocks Beach,  FL  34635
Correspondent Contact MARK A HAGOPIAN
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received05/20/1988
Decision Date 08/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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