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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 K873546
Device Name VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM
Applicant
Reimers Engineering, Inc.
6314-K Gravel Ave.
Alexandria,  VA  22310
Applicant Contact REIMERS, P.E.
Correspondent
Reimers Engineering, Inc.
6314-K Gravel Ave.
Alexandria,  VA  22310
Correspondent Contact REIMERS, P.E.
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received09/01/1987
Decision Date 01/29/1988
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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