The following data is part of a premarket notification filed by Denver Biomedicals, Inc. with the FDA for Tunneler.
| Device ID | K943968 |
| 510k Number | K943968 |
| Device Name: | TUNNELER |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | DENVER BIOMEDICALS, INC. 6851 HIGHWAY 73 Evergreen, CO 80439 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard DENVER BIOMEDICALS, INC. 6851 HIGHWAY 73 Evergreen, CO 80439 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-15 |
| Decision Date | 1995-03-01 |