The following data is part of a premarket notification filed by M.k. Meditech Co. Ltd. with the FDA for 10 Ml Bak'snap Duopross Retractable Safety Syringe.
| Device ID | K034031 |
| 510k Number | K034031 |
| Device Name: | 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | M.K. MEDITECH CO. LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson M.K. MEDITECH CO. LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-29 |
| Decision Date | 2004-01-21 |
| Summary: | summary |