Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K173644 |
Device Name |
Gazelle Polypropylene Suture and Delivery Device |
Applicant |
Dura Tap LLC |
208 Upland Way |
Wayne,
PA
19087
|
|
Applicant Contact |
Ann R. Lee |
Correspondent |
Ambriel Associates, Inc. |
411 Walnut St. Unit 9236 |
Green Cove Springs,
FL
32043
|
|
Correspondent Contact |
Vikki M. O'Connor |
Regulation Number | 878.5010
|
Classification Product Code |
|
Date Received | 11/27/2017 |
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
|