The following data is part of a premarket notification filed by M.k. Meditech Co. Ltd. with the FDA for Bak'snap Duopro Safety Syring (duopross) Safety'tray Allergy Safety Syringe Tray.
| Device ID | K031594 |
| 510k Number | K031594 |
| Device Name: | BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-21 |
| Decision Date | 2003-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784693033 | K031594 | 000 |
| 00616784691633 | K031594 | 000 |
| 00616784691732 | K031594 | 000 |
| 00616784691831 | K031594 | 000 |
| 00616784691930 | K031594 | 000 |
| 00616784692036 | K031594 | 000 |
| 00616784692135 | K031594 | 000 |
| 00616784692234 | K031594 | 000 |
| 00616784692333 | K031594 | 000 |
| 00616784692432 | K031594 | 000 |
| 00616784692531 | K031594 | 000 |
| 00616784692630 | K031594 | 000 |
| 00616784692739 | K031594 | 000 |
| 00616784692838 | K031594 | 000 |
| 00616784692937 | K031594 | 000 |
| 00616784691534 | K031594 | 000 |