The following data is part of a premarket notification filed by Medicalchain Internartional Corporation with the FDA for Mysafety Syringe.
| Device ID | K113673 |
| 510k Number | K113673 |
| Device Name: | MYSAFETY SYRINGE |
| Classification | Syringe, Piston |
| Applicant | MEDICALCHAIN INTERNARTIONAL CORPORATION 1808 SEABREEZE COURT Thousand Oaks, CA 91320 |
| Contact | Robin Hwang |
| Correspondent | Robin Hwang MEDICALCHAIN INTERNARTIONAL CORPORATION 1808 SEABREEZE COURT Thousand Oaks, CA 91320 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-13 |
| Decision Date | 2012-08-03 |
| Summary: | summary |