The following data is part of a premarket notification filed by Summit Medical Products, Inc with the FDA for Ambit Tunneler.
| Device ID | K110814 |
| 510k Number | K110814 |
| Device Name: | AMBIT TUNNELER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | SUMMIT MEDICAL PRODUCTS, INC 2480 SOUTH MAIN STREET #212 Salt Lake City, UT 84118 |
| Contact | Marko V Amen |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-24 |
| Decision Date | 2011-04-08 |
| Summary: | summary |