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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K920437
Device Name SYNTHETIC ABSORBABLE SUTURE, UNDYED
Applicant
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Applicant Contact JOHN D.PAULSON
Correspondent
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact JOHN D.PAULSON
Regulation Number878.5010
Classification Product Code
GAW  
Date Received02/03/1992
Decision Date 07/30/1992
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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