The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Sabreline And Sabreguard Laser Fibers.
| Device ID | K182831 |
| 510k Number | K182831 |
| Device Name: | SabreLine And SabreGuard Laser Fibers |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Cori Ragan |
| Correspondent | Cori Ragan Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-09 |
| Decision Date | 2018-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932688543 | K182831 | 000 |
| 05708932688277 | K182831 | 000 |
| 05708932688307 | K182831 | 000 |
| 05708932688338 | K182831 | 000 |
| 05708932688369 | K182831 | 000 |
| 05708932688390 | K182831 | 000 |
| 05708932688420 | K182831 | 000 |
| 05708932688451 | K182831 | 000 |
| 05708932688482 | K182831 | 000 |
| 05708932688512 | K182831 | 000 |
| 05708932687058 | K182831 | 000 |