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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K963067
Device Name SOF. PRESS EPC 51 SYSTEM
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 Number870.5800
Classification Product Code
JOW  
Date Received08/07/1996
Decision Date 01/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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