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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K942319
Device Name HIRSCH BIPOLAR COAGULATION FORCEPS AND ADAPTOR CABLES
Applicant
Berchtold Holding GmbH
Ludwigstaler St. 25
Tuttlingen,  DE D-78532
Applicant Contact DAVID N BULMAN
Correspondent
Berchtold Holding GmbH
Ludwigstaler St. 25
Tuttlingen,  DE D-78532
Correspondent Contact DAVID N BULMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/13/1994
Decision Date 06/08/1994
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
Predetermined Change
Control Plan Authorized		 No
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