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 |