The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Saffron Fixation System.
| Device ID | K220420 |
| 510k Number | K220420 |
| Device Name: | Saffron Fixation System |
| Classification | Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Applicant | Coloplast A/S 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Gayatri Ghadge |
| Correspondent | Gayatri Ghadge Coloplast A/S 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | PBQ |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932757430 | K220420 | 000 |
| 05708932757423 | K220420 | 000 |