The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Anchor.
| Device ID | K892126 |
| 510k Number | K892126 |
| Device Name: | MITEK ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 990 WASHINGTON ST. Dedham, MA 02026 |
| Contact | Edward F Kent |
| Correspondent | Edward F Kent MITEK SURGICAL PRODUCTS, INC. 990 WASHINGTON ST. Dedham, MA 02026 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-30 |
| Decision Date | 1989-09-19 |