The following data is part of a premarket notification filed by Surgical Devices, A Global Business Unit Tyco with the FDA for Autosuture Eea Orvil.
| Device ID | K093402 |
| 510k Number | K093402 |
| Device Name: | AUTOSUTURE EEA ORVIL |
| Classification | Staple, Implantable |
| Applicant | SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Rebecca Ronner |
| Correspondent | Rebecca Ronner SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-02 |
| Decision Date | 2009-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521042855 | K093402 | 000 |
| 20884521042879 | K093402 | 000 |