The following data is part of a premarket notification filed by Covidien with the FDA for Absorbatack 5mm Single Use Absorbable Fixation Device.
| Device ID | K123109 |
| 510k Number | K123109 |
| Device Name: | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Contact | Renee Borgesano |
| Correspondent | Renee Borgesano 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 | 2012-10-04 |
| Decision Date | 2012-10-23 |
| Summary: | summary |