The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Cufftack.
| Device ID | K003076 |
| 510k Number | K003076 |
| Device Name: | MITEK CUFFTACK |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Christine Kuntz-nassif |
| Correspondent | Christine Kuntz-nassif MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2000-10-27 |