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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 K934817
Device Name SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS
Applicant
Surgical Design Corp.
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact WAYNE H MATELSKI
Correspondent
Surgical Design Corp.
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact WAYNE H MATELSKI
Regulation Number880.5550
Classification Product Code
FNM  
Date Received10/05/1993
Decision Date 06/17/1994
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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