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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.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact JOHN D PAULSON
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
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
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