The following data is part of a premarket notification filed by Covidien, Formerly Us Surgical A Divison Of Tyco H with the FDA for Reliamax Gastrointestinal Anastomosis And Reload.
| Device ID | K122781 |
| 510k Number | K122781 |
| Device Name: | RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 60 Middletown Ave North Haven, CT 06473 |
| Contact | Mary Mellows |
| Correspondent | Mary Mellows COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H 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 | 2012-09-11 |
| Decision Date | 2013-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521168640 | K122781 | 000 |
| 10884521168633 | K122781 | 000 |
| 10884521168626 | K122781 | 000 |
| 10884521168619 | K122781 | 000 |
| 10884521168602 | K122781 | 000 |
| 10884521174894 | K122781 | 000 |
| 10884521174887 | K122781 | 000 |