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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 K914851
Device Name CLA-1400 SYSTEM
Applicant
Gaymar Industries, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Applicant Contact PETER SCOTT
Correspondent
Gaymar Industries, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Correspondent Contact PETER SCOTT
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received10/28/1991
Decision Date 11/13/1991
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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