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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K914108
Device Name RG27-SERIES RESECTOSCOPE AND ACCESSORIES
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 Number884.1690
Classification Product Code
HIH  
Date Received09/13/1991
Decision Date 03/19/1992
Decision Substantially Equivalent (SESE)
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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