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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 K903146
Device Name HYSTEROSCOPY SHEATH SET
Applicant
Cook, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
Cook, Inc.
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number884.1690
Classification Product Code
HIH  
Date Received07/18/1990
Decision Date 10/12/1990
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
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