The following data is part of a premarket notification filed by Surgical Devices, A Division Of Tyco Healthcare with the FDA for Auto Suture Endo Clip Iii5mm Clip Adapter.
| Device ID | K100242 |
| 510k Number | K100242 |
| Device Name: | AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER |
| Classification | Clip, Implantable |
| Applicant | SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Contact | Nishith Desai |
| Correspondent | Nishith Desai SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-27 |
| Decision Date | 2010-02-17 |
| Summary: | summary |