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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Patient Rotation, Powered
510(k) Number K962788
Device Name CLINIDYNE ROTATIONAL THERAPY MATTRESS 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 Number890.5225
Classification Product Code
IKZ  
Subsequent Product Codes
FNM   IOQ  
Date Received07/17/1996
Decision Date 04/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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