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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Flotation Therapy, Non-Powered
510(k) Number K914921
Device Name SCM-3 AND ACCESSORIES
Applicant
Gaymar Industries, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Applicant Contact PETER J SCOTT
Correspondent
Gaymar Industries, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Correspondent Contact PETER J SCOTT
Regulation Number880.5150
Classification Product Code
IKY  
Date Received11/04/1991
Decision Date 03/12/1992
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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