The following data is part of a premarket notification filed by Mitek Products with the FDA for Mitek Absorbable Polydioxanone (pds) H Fix.
| Device ID | K970119 |
| 510k Number | K970119 |
| Device Name: | MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX |
| Classification | Fastener, Fixation, Nondegradable, 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-14 |
| Decision Date | 1998-01-30 |
| Summary: | summary |