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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 K965207
Device Name RID-DECUBE II
Applicant
Skin Care Management, Inc.
29 Ainsworth Ave.
East Burnswick,  NJ  08816
Applicant Contact ERIC FLAM, PH.D.
Correspondent
Skin Care Management, Inc.
29 Ainsworth Ave.
East Burnswick,  NJ  08816
Correspondent Contact ERIC FLAM, PH.D.
Regulation Number880.5550
Classification Product Code
FNM  
Date Received12/27/1996
Decision Date 08/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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