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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 K880486
Device Name DERMGARD SYSTEM 800 AND 900
Applicant
Dermgard, Inc.
14 Wall St.
New York,  NY  10005
Applicant Contact MARK HAGOPIAN
Correspondent
Dermgard, Inc.
14 Wall St.
New York,  NY  10005
Correspondent Contact MARK HAGOPIAN
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received02/04/1988
Decision Date 02/22/1988
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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