The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Tegress Implant Needle.
| Device ID | K050688 |
| 510k Number | K050688 |
| Device Name: | TEGRESS IMPLANT NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Terri Morris |
| Correspondent | Terri Morris C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-17 |
| Decision Date | 2005-04-06 |
| Summary: | summary |