The following data is part of a premarket notification filed by Gyrx, Llc with the FDA for Ti Clip Applier.
| Device ID | K034029 |
| 510k Number | K034029 |
| Device Name: | TI CLIP APPLIER |
| Classification | Clip, Vas Deferens |
| Applicant | GYRX, LLC 11222 ST. JOHNS INDUSTRIAL PARKWAY N. Jacksonville, FL 32246 |
| Contact | Brian S Zimovan |
| Correspondent | Brian S Zimovan GYRX, LLC 11222 ST. JOHNS INDUSTRIAL PARKWAY N. Jacksonville, FL 32246 |
| Product Code | NJC |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-29 |
| Decision Date | 2004-03-05 |
| Summary: | summary |