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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic
510(k) Number K920978
Device Name ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED
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 Number878.4830
Classification Product Code
GAN  
Subsequent Product Code
GAM  
Date Received03/02/1992
Decision Date 02/15/1994
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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