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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K970968
Device Name BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
Applicant
Guenter Bissinger Medizintechnik GmbH
Gottlieb-Daimler-Str. 5
(Rohrlache)
Teningen,  DE D-79331
Applicant Contact DAVID W SCHLERF
Correspondent
Guenter Bissinger Medizintechnik GmbH
Gottlieb-Daimler-Str. 5
(Rohrlache)
Teningen,  DE D-79331
Correspondent Contact DAVID W SCHLERF
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
KNS  
Date Received03/17/1997
Decision Date 05/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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