The following data is part of a premarket notification filed by Byrne Medical Inc. with the FDA for Erbelift Hand Pump And Flexible Probe.
| Device ID | K092090 |
| 510k Number | K092090 |
| Device Name: | ERBELIFT HAND PUMP AND FLEXIBLE PROBE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | BYRNE MEDICAL INC. 3150 POLLOK DR Conroe, TX 77303 |
| Contact | Chris Hierholzer |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-14 |
| Decision Date | 2009-11-30 |
| Summary: | summary |