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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope
510(k) Number K964892
Device Name FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
Applicant
Gynecare Innovation Center
1221 Innsbruck Dr.
Sunnyvale,  CA  94089
Applicant Contact JOHN N ZORICH
Correspondent
Gynecare Innovation Center
1221 Innsbruck Dr.
Sunnyvale,  CA  94089
Correspondent Contact JOHN N ZORICH
Regulation Number876.1500
Classification Product Code
FJL  
Date Received12/06/1996
Decision Date 02/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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