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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, Polyglycolic Acid
510(k) Number K042141
Device Name POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
Applicant
TELEFLEX MEDICAL
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Applicant Contact STEVE ASTORINO
Correspondent
TELEFLEX MEDICAL
600 AIRPORT RD.
FALL RIVER,  MA  02720 -4740
Correspondent Contact STEVE ASTORINO
Regulation Number878.4493
Classification Product Code
GAM  
Date Received08/09/2004
Decision Date 09/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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