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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Snare, Flexible
510(k) Number K073288
Device Name ETHICON ENDO SURGERY ARTICULATING SNARE
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242 -2839
Applicant Contact GLENDA C MARSH
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242 -2839
Correspondent Contact GLENDA C MARSH
Regulation Number876.4300
Classification Product Code
FDI  
Date Received11/21/2007
Decision Date 06/12/2008
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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