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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 K971836
Device Name VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
Applicant
COOPERSURGICAL, INC.
15 FOREST PKWY.
SHELTON,  CT  06484
Applicant Contact DEBRA A PEKAR
Correspondent
COOPERSURGICAL, INC.
15 FOREST PKWY.
SHELTON,  CT  06484
Correspondent Contact DEBRA A PEKAR
Regulation Number884.1720
Classification Product Code
HET  
Date Received05/19/1997
Decision Date 11/07/1997
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
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