The following data is part of a premarket notification filed by Depuy Mitek with the FDA for Blue Orthocord Suture.
| Device ID | K043298 |
| 510k Number | K043298 |
| Device Name: | BLUE ORTHOCORD SUTURE |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | Depuy Mitek 249 VANDERBILT DR. Norwood, MA 02062 |
| Contact | Ruth C Forstadt |
| Correspondent | Ruth C Forstadt Depuy Mitek 249 VANDERBILT DR. Norwood, MA 02062 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-30 |
| Decision Date | 2004-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705008848 | K043298 | 000 |
| 20886705008831 | K043298 | 000 |
| 20886705008817 | K043298 | 000 |