The following data is part of a premarket notification filed by Covidien with the FDA for Autosuture Protack; Tacker System; Absorbatack Fixation Devices.
| Device ID | K090470 |
| 510k Number | K090470 |
| Device Name: | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | COVIDIEN 60 MIDDLETWON DR North Haven, CT 06473 |
| Contact | Jennifer Brennan |
| Correspondent | Jennifer Brennan COVIDIEN 60 MIDDLETWON DR North Haven, CT 06473 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-23 |
| Decision Date | 2009-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521070452 | K090470 | 000 |
| 10884521070479 | K090470 | 000 |