The following data is part of a premarket notification filed by Mitek Products with the FDA for Bioknotless Anchor.
| Device ID | K002639 |
| 510k Number | K002639 |
| Device Name: | BIOKNOTLESS ANCHOR |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Contact | Mary P Legraw |
| Correspondent | Mary P Legraw MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-24 |
| Decision Date | 2001-05-11 |
| Summary: | summary |