The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Absorbable Anchor.
| Device ID | K941599 |
| 510k Number | K941599 |
| Device Name: | MITEK ABSORBABLE ANCHOR |
| Classification | Strip, Dialysate Ph Indicator |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 60 GLACIER DR. Westwood, MA 02090 |
| Contact | Edward F Kent |
| Correspondent | Edward F Kent MITEK SURGICAL PRODUCTS, INC. 60 GLACIER DR. Westwood, MA 02090 |
| Product Code | MNV |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-01 |
| Decision Date | 1995-10-24 |