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FDA 510(k) Application Details - K171494
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
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510(K) Number
K171494
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
Gordian Surgical Ltd.
17 Tchelet Street
Misgav Business Park 2017400 IL
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Contact
Amir Schvartzer
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
05/22/2017
Decision Date
06/15/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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