The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Suturetape.
Device ID | K171296 |
510k Number | K171296 |
Device Name: | SutureTape |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Contact | Ivette Galmez |
Correspondent | Ivette Galmez Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-02 |
Decision Date | 2017-05-26 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SUTURETAPE 87768599 not registered Dead/Abandoned |
RIVERPOINT LLC 2018-01-24 |
SUTURETAPE 86244208 not registered Dead/Abandoned |
Riverpoint LLC 2014-04-07 |