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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 K903663
Device Name MEDSCOPE 8MM AND 10MM LAPAROSCOPE
Applicant
MEDSCOPE CORP.
495 LINDBERG LN.
NORTHBROOK,  IL  60062
Applicant Contact JOACHIM SOUESS
Correspondent
MEDSCOPE CORP.
495 LINDBERG LN.
NORTHBROOK,  IL  60062
Correspondent Contact JOACHIM SOUESS
Regulation Number884.1720
Classification Product Code
HET  
Date Received08/14/1990
Decision Date 02/11/1992
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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