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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 K890328
Device Name ADULT RESECTOSCOPE
Applicant
Circon Video
300 Stillwater Ave.
P.O. Box Box 1971
Stanford,  CT  06904 -1971
Applicant Contact TAYLOR, PE
Correspondent
Circon Video
300 Stillwater Ave.
P.O. Box Box 1971
Stanford,  CT  06904 -1971
Correspondent Contact TAYLOR, PE
Regulation Number884.1690
Classification Product Code
HIH  
Date Received01/23/1989
Decision Date 02/06/1990
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
Recalls CDRH Recalls
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