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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K864350
Device Name VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER
Applicant
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Applicant Contact ROBERT O'HOLLA
Correspondent
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact ROBERT O'HOLLA
Regulation Number878.4300
Classification Product Code
FZP  
Date Received11/04/1986
Decision Date 12/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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