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FDA 510(k) Application Details - K221744
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
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510(K) Number
K221744
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
Ethicon, Inc.
1000 US-202
Raritan, NJ 08869-1425 US
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Contact
Jenny Wang
Other 510(k) Applications for this Contact
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
06/16/2022
Decision Date
11/15/2022
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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