The following data is part of a premarket notification filed by Neomedic International S.l. with the FDA for Anchorsure.
| Device ID | K120831 |
| 510k Number | K120831 |
| Device Name: | ANCHORSURE |
| Classification | Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Applicant | NEOMEDIC INTERNATIONAL S.L. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman NEOMEDIC INTERNATIONAL S.L. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Product Code | PBQ |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-10-12 |
| Summary: | summary |