Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-