The following data is part of a premarket notification filed by Covidien with the FDA for Reliatack Articulating Reloadable Fixation Device With Standard Purchase Absorble Tacks.
| Device ID | K140609 |
| 510k Number | K140609 |
| Device Name: | RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN 60 Middletown Ave North Haven, CT 06473 |
| Contact | Clare Santulli |
| Correspondent | Clare Santulli COVIDIEN 60 Middletown Ave 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 | 2014-03-10 |
| Decision Date | 2014-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521202412 | K140609 | 000 |
| 10884521202382 | K140609 | 000 |
| 20884521726342 | K140609 | 000 |
| 20884521726335 | K140609 | 000 |