The following data is part of a premarket notification filed by Us Infusion Inc. D/b/a Truecare Biomedix-usa with the FDA for Truecare Biomedix Tamper Evident Cap.
| Device ID | K210818 |
| 510k Number | K210818 |
| Device Name: | TrueCare Biomedix Tamper Evident Cap |
| Classification | Syringe, Piston |
| Applicant | US Infusion Inc. D/B/A Truecare Biomedix-USA 6356 Manor Ln Ste 101 South Miami, FL 33143 |
| Contact | Abbey Kramarz |
| Correspondent | Abbey Kramarz US Infusion Inc. D/B/A Truecare Biomedix-USA 6356 Manor Ln Ste 101 South Miami, FL 33143 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-18 |
| Decision Date | 2021-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40850789007657 | K210818 | 000 |