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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 K971305
Device Name FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
Applicant
GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE,  CA  94089
Applicant Contact GEORGE M SAVAGE
Correspondent
GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE,  CA  94089
Correspondent Contact GEORGE M SAVAGE
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
KNF  
Date Received04/08/1997
Decision Date 08/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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