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510(k) K173644

Gazelle Polypropylene Suture and Delivery Device by Dura Tap, LLC — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2018
Date Received
November 27, 2017
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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