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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polypropylene
510(k) Number K173644
Device Name Gazelle Polypropylene Suture and Delivery Device
Dura Tap LLC
208 Upland Way
Wayne,  PA  19087
Applicant Contact Ann R. Lee
Ambriel Associates, Inc.
411 Walnut St. Unit 9236
Green Cove Springs,  FL  32043
Correspondent Contact Vikki M. O'Connor
Regulation Number878.5010
Classification Product Code
Date Received11/27/2017
Decision Date 02/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No