The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Sterilization Tray.
| Device ID | K893886 |
| 510k Number | K893886 |
| Device Name: | MITEK STERILIZATION TRAY |
| Classification | Sterilizer, Steam |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 990 WASHINGTON ST. Dedham, MA 02026 |
| Contact | Robert Zoletti |
| Correspondent | Robert Zoletti MITEK SURGICAL PRODUCTS, INC. 990 WASHINGTON ST. Dedham, MA 02026 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-30 |
| Decision Date | 1989-08-21 |