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FDA 510(k) Application Details - K042141
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
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510(K) Number
K042141
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
TELEFLEX MEDICAL
600 AIRPORT RD.
FALL RIVER, MA 02720-4740 US
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Contact
STEVE ASTORINO
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Regulation Number
878.4493
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Classification Product Code
GAM
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More FDA Info for this Product Code
Date Received
08/09/2004
Decision Date
09/28/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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