The following data is part of a premarket notification filed by Covidien with the FDA for Surgical Gut Suture.
| Device ID | K142656 |
| 510k Number | K142656 |
| Device Name: | Surgical Gut Suture |
| Classification | Suture, Absorbable, Natural |
| Applicant | COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Contact | Mary Mellows |
| Correspondent | Mary Mellows COVIDIEN 60 MIDDLETOWN AVE. North Haven, CT 06473 |
| Product Code | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-18 |
| Decision Date | 2015-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10612479214764 | K142656 | 000 |
| 10612479214740 | K142656 | 000 |
| 10612479213132 | K142656 | 000 |
| 10612479213118 | K142656 | 000 |
| 10612479213095 | K142656 | 000 |
| 20884521548333 | K142656 | 000 |
| 20884521548326 | K142656 | 000 |