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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cup, menstrual
510(k) Number K910254
Device Name DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
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 Number884.5400
Classification Product Code
HHE  
Date Received01/22/1991
Decision Date 04/18/1991
Decision substantially equivalent - with drug (SESD)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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