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FDA 510(k) Application Details - K212888
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyamide
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510(K) Number
K212888
Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Applicant
Antarma LLC dba Golnit Sutures
276 5th Ave., Suite 704
New York, NY 10001 US
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Contact
Armine Badalyan
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Regulation Number
878.5020
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Classification Product Code
GAR
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More FDA Info for this Product Code
Date Received
09/10/2021
Decision Date
03/31/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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