The following data is part of a premarket notification filed by Intl. Medical Prosthetics Research with the FDA for Kelly-wick Tanneler.
| Device ID | K830471 |
| 510k Number | K830471 |
| Device Name: | KELLY-WICK TANNELER |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | INTL. MEDICAL PROSTHETICS RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-03-24 |