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510(k) K171494

TroClose1200, TroClose1200 Cannula by Gordian Surgical, Ltd. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2017
Date Received
May 22, 2017
Clearance Type
Special
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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  • K160564 — TroClose1200 (November 17, 2016)

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