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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 K924005
Device Name SANKEN MAT
Applicant
Shima American Corp.
1819 H St., NW
Washington,  DC  20006
Applicant Contact ANSIS M HELMANIS
Correspondent
Shima American Corp.
1819 H St., NW
Washington,  DC  20006
Correspondent Contact ANSIS M HELMANIS
Regulation Number880.5550
Classification Product Code
FNM  
Date Received08/10/1992
Decision Date 06/17/1993
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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