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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 K070151
Device Name INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER
Applicant
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Applicant Contact KIMBERLY SHOEMAKER
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact KIMBERLY SHOEMAKER
Regulation Number876.1500
Classification Product Code
OCW  
Subsequent Product Codes
GAW   MXW  
Date Received01/16/2007
Decision Date 08/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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