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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 St., Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
Coopersurgical Inc.,
C/O Charles I. Rose & Co, Inc.
1963 Rock St., 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
Predetermined Change
Control Plan Authorized		 No
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