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510(k) K160564

TroClose1200 by Gordian Surgical, Ltd. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2016
Date Received
February 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

Other clearances by Gordian Surgical, Ltd.

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  • K171494 — TroClose1200, TroClose1200 Cannula (June 15, 2017)

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