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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 K954648
Device Name FEMRX OPERASTAR SYSTEM
Applicant
Gynecare Innovation Center
1221 Innsbruck Dr.
Sunnyvale,  CA  94089
Applicant Contact MICHAEL A DANIEL
Correspondent
Gynecare Innovation Center
1221 Innsbruck Dr.
Sunnyvale,  CA  94089
Correspondent Contact MICHAEL A DANIEL
Regulation Number884.1690
Classification Product Code
HIH  
Date Received10/10/1995
Decision Date 03/14/1996
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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