The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As United States with the FDA for Absorbatack 5mm Single Use Absorbable Fixation Device.
| Device ID | K091900 |
| 510k Number | K091900 |
| Device Name: | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE |
| Classification | Staple, Implantable |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE North Haven, CT 06473 |
| Contact | Rebecca Ronner |
| Correspondent | Rebecca Ronner COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 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 | 2009-06-25 |
| Decision Date | 2009-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10613830159380 | K091900 | 000 |
| 10613830159373 | K091900 | 000 |
| 20884523006152 | K091900 | 000 |