The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Omnicut Resection Blade.
| Device ID | K130912 |
| 510k Number | K130912 |
| Device Name: | OMNICUT RESECTION BLADE |
| Classification | Arthroscope |
| Applicant | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Tatyana Korsunsky |
| Correspondent | Tatyana Korsunsky DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-02 |
| Decision Date | 2013-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705022509 | K130912 | 000 |
| 20886705022493 | K130912 | 000 |
| 20886705022486 | K130912 | 000 |
| 20886705022479 | K130912 | 000 |