The following data is part of a premarket notification filed by Tyco Healthcare Group, Lp with the FDA for Auto Suture Endo Gia Staplers With Endo Gia Single Use Loading Units With Staple Line Reinforcement.
| Device ID | K080898 |
| 510k Number | K080898 |
| Device Name: | AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT |
| Classification | Staple, Implantable |
| Applicant | TYCO HEALTHCARE GROUP, LP 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Contact | Sharon Alexander |
| Correspondent | Sharon Alexander TYCO HEALTHCARE GROUP, LP 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-05-05 |
| Summary: | summary |