The following data is part of a premarket notification filed by Medicalchain Intl. Corp. with the FDA for Mysafety Syringe.
| Device ID | K111734 |
| 510k Number | K111734 |
| Device Name: | MYSAFETY SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | MEDICALCHAIN INTL. CORP. 1808 SEABREEZE COUNT, Thousand Oaks, CA 91320 |
| Contact | Robin Hwang |
| Correspondent | Robin Hwang MEDICALCHAIN INTL. CORP. 1808 SEABREEZE COUNT, Thousand Oaks, CA 91320 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-21 |
| Decision Date | 2011-09-06 |
| Summary: | summary |