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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ligator, Esophageal
510(k) Number K051950
Device Name INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Applicant Contact KIMBERLY SHOEMAKER
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact KIMBERLY SHOEMAKER
Regulation Number876.4400
Classification Product Code
MND  
Subsequent Product Codes
FHN   HBT   MCH   OCW  
Date Received07/18/2005
Decision Date 10/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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