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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 K100585
Device Name MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
Applicant
GAYMAR INDUSTRIES, INC.
10 CENTRE DR.
ORCHARD PARK,  NY  14127
Applicant Contact BRIAN L ORWAT
Correspondent
GAYMAR INDUSTRIES, INC.
10 CENTRE DR.
ORCHARD PARK,  NY  14127
Correspondent Contact BRIAN L ORWAT
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received03/02/2010
Decision Date 01/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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