The following data is part of a premarket notification filed by Dura Tap Llc with the FDA for Gazelle Ptfe And Suture Delivery Device.
| Device ID | K173335 |
| 510k Number | K173335 |
| Device Name: | Gazelle PTFE And Suture Delivery Device |
| Classification | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Applicant | Dura Tap LLC 208 Upland Way Wayne, PA 19087 |
| Contact | Ann R. Lee |
| Correspondent | Vikki M. O'connor Ambriel Associates, Inc. 411 Walnut St. Unit 9236 Green Cove Springs, FL 32043 |
| Product Code | NBY |
| CFR Regulation Number | 878.5035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-23 |
| Decision Date | 2018-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B532GZL0020 | K173335 | 000 |