The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Absorbable Toggle Anchor.
| Device ID | K964013 |
| 510k Number | K964013 |
| Device Name: | MITEK ABSORBABLE TOGGLE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Contact | Edward F Kent |
| Correspondent | Edward F Kent MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1997-02-24 |
| Summary: | summary |