The following data is part of a premarket notification filed by S.i.n. - Sistema De Implante Nacional S.a. with the FDA for S.i.n. Instrument Kits.
| Device ID | K212404 |
| 510k Number | K212404 |
| Device Name: | S.I.N. Instrument Kits |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | S.I.N. - Sistema De Implante Nacional S.A. Avenida Vereador Abel Ferreira, 1100 São Paulo, BR 03340-000 |
| Contact | Denise Domiciano |
| Correspondent | Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-02 |
| Decision Date | 2021-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899995200105 | K212404 | 000 |
| 07899995274670 | K212404 | 000 |
| 07899995265845 | K212404 | 000 |
| 07899995258854 | K212404 | 000 |
| 07899995264824 | K212404 | 000 |