The following data is part of a premarket notification filed by Covidien Llc with the FDA for Reliatack Articulating Reloadable Fixation Device With Deep Purchase Reloadable Tacks.
| Device ID | K151659 |
| 510k Number | K151659 |
| Device Name: | ReliaTack Articulating Reloadable Fixation Device With Deep Purchase Reloadable Tacks |
| Classification | Staple, Implantable |
| Applicant | Covidien LLC 60 Middletown Avenue North Haven, CT 06473 |
| Contact | Mary Mellows |
| Correspondent | Mary Mellows Covidien LLC 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 | 2015-06-19 |
| Decision Date | 2015-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521202405 | K151659 | 000 |
| 10884521202375 | K151659 | 000 |
| 20884521726366 | K151659 | 000 |
| 20884521726359 | K151659 | 000 |
| 20884521726380 | K151659 | 000 |
| 40884521202420 | K151659 | 000 |