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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K091290
Device Name ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact TOM BOSTICCO
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact TOM BOSTICCO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/01/2009
Decision Date 10/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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