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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 K033177
Device Name POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
Applicant
GUNTER BISSINGER MEDIZINTECHNIK GMBH
AMSTEL 320-I
AMSTERDAM,  NL 1017 AP
Applicant Contact DAGMAR MASER
Correspondent
GUNTER BISSINGER MEDIZINTECHNIK GMBH
AMSTEL 320-I
AMSTERDAM,  NL 1017 AP
Correspondent Contact DAGMAR MASER
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
KNS  
Date Received10/01/2003
Decision Date 03/11/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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