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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 K944270
Device Name CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS
Applicant
CHIRURGISCHE INSTRUMENTE
HAUPTSTRABE 18
BALGHEIM,  DE D-78582
Applicant Contact BEATE SCHOPPLER
Correspondent
CHIRURGISCHE INSTRUMENTE
HAUPTSTRABE 18
BALGHEIM,  DE D-78582
Correspondent Contact BEATE SCHOPPLER
Regulation Number884.1720
Classification Product Code
HET  
Date Received09/01/1994
Decision Date 07/25/1995
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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