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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name speculum, vaginal, nonmetal
510(k) Number K951898
Device Name VERSA-VU
Applicant
COOPERSURGICAL, INC.
15 FOREST PKWY.
SHELTON,  CT  06484
Applicant Contact JOHN CHAPMAN
Correspondent
COOPERSURGICAL, INC.
15 FOREST PKWY.
SHELTON,  CT  06484
Correspondent Contact JOHN CHAPMAN
Regulation Number884.4530
Classification Product Code
HIB  
Date Received04/24/1995
Decision Date 12/11/1995
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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