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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 K933768
FOIA Releasable 510(k) K933768
Device Name COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES
Applicant
MAHE-MEDIZINTECHNIK
300 JAMES ROBERTSON PKWY.
NASHVILLE,  TN  37201
Applicant Contact WINFRIED REICH
Correspondent
MAHE-MEDIZINTECHNIK
300 JAMES ROBERTSON PKWY.
NASHVILLE,  TN  37201
Correspondent Contact WINFRIED REICH
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/29/1993
Decision Date 06/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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