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 |