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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 K162562
Device Name OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
Applicant
Bcg Medical, LLC
6715 Rancho Toyon Pl.
San Diego,  CA  92130
Applicant Contact LISA GIAP
Correspondent
Bcg Medical, LLC
6715 Rancho Toyon Pl.
San Diego,  CA  92130
Correspondent Contact LISA GIAP
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received09/14/2016
Decision Date 03/17/2017
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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