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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Anesthesia, Paracervical
510(k) Number K910253
Device Name LEEP REDIKIT
Applicant
COOPERSURGICAL, INC.
C/O CHARLES I. ROSE & CO., INC
1963 ROCK STREET, SUITE #17
MOUNTAIN VIEW,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
COOPERSURGICAL, INC.
C/O CHARLES I. ROSE & CO., INC
1963 ROCK STREET, SUITE #17
MOUNTAIN VIEW,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number884.5100
Classification Product Code
HEE  
Date Received01/22/1991
Decision Date 04/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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