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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K942881
Device Name TC 3000
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 Number870.5900
Classification Product Code
DWJ  
Date Received06/17/1994
Decision Date 05/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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