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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Surgical
510(k) Number K123776
Device Name POLARIS 100/200
Applicant
Drager Medical GmbH
6 Tech Dr.
Andover,  MA  01810
Applicant Contact BETH ZIS
Correspondent
Drager Medical GmbH
6 Tech Dr.
Andover,  MA  01810
Correspondent Contact BETH ZIS
Regulation Number878.4580
Classification Product Code
FTD  
Date Received12/10/2012
Decision Date 03/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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