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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, electrosurgical
510(k) Number K881334
Device Name LIGHT COAGULATOR LC 250
Applicant
NK-OPTIK GMBH
FORSTENRIEDER ALLEE 221
MUNICH D8000,  DE
Applicant Contact ALBERT KREITMAIR
Correspondent
NK-OPTIK GMBH
FORSTENRIEDER ALLEE 221
MUNICH D8000,  DE
Correspondent Contact ALBERT KREITMAIR
Regulation Number878.4400
Classification Product Code
HAM  
Date Received03/30/1988
Decision Date 11/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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