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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Esophageal
510(k) Number K093236
Device Name ETHICON ENDO-SURGERYOPTICAL DILATOR
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact RENEE ROWE
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact RENEE ROWE
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received10/15/2009
Decision Date 11/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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