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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic tissue approximation device
510(k) Number K033269
FOIA Releasable 510(k) K033269
Device Name ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Applicant Contact GEORGIA C ABERNATHY
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact GEORGIA C ABERNATHY
Regulation Number876.1500
Classification Product Code
OCW  
Subsequent Product Code
GDW  
Date Received10/09/2003
Decision Date 12/10/2003
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
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