The following data is part of a premarket notification filed by M.k. Meditech Co. Ltd. with the FDA for Insosafe Bak'snap Retractable Insulin Safety Syringe.
| Device ID | K050131 |
| 510k Number | K050131 |
| Device Name: | INSOSAFE BAK'SNAP RETRACTABLE INSULIN 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-21 |
| Decision Date | 2005-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784690537 | K050131 | 000 |
| 00616784690438 | K050131 | 000 |
| 00616784690339 | K050131 | 000 |
| 00616784690230 | K050131 | 000 |
| 00616784690131 | K050131 | 000 |