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510(k) K160529

Pledgeted COR-SUTURE QUICK LOAD by Lsi Soultions — Product Code GAW

K160529 is an FDA 510(k) premarket notification submitted by Lsi Soultions for the device "Pledgeted COR-SUTURE QUICK LOAD". The FDA issued a decision of Substantially Equivalent on September 15, 2016. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2016
Date Received
February 25, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

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FDA data resources