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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 K021237
Device Name COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
Applicant
Coopersurgical Inc.,
Kaiserstr.9
Tuningen,  DE D-78609
Applicant Contact HAIKO BELL
Correspondent
Coopersurgical Inc.,
Kaiserstr.9
Tuningen,  DE D-78609
Correspondent Contact HAIKO BELL
Regulation Number884.1720
Classification Product Code
HET  
Date Received04/18/2002
Decision Date 04/10/2003
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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