The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Mini Anchor.
| Device ID | K936311 |
| 510k Number | K936311 |
| Device Name: | MITEK MINI ANCHOR |
| Classification | Strip, Dialysate Ph Indicator |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| Contact | Edward F Kent |
| Correspondent | Edward F Kent MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| 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 | 1994-04-20 |
| Decision Date | 1995-10-31 |