The following data is part of a premarket notification filed by Medexel Medical Mfg. Co., Ltd. with the FDA for P&p Safety Syringe.
| Device ID | K043419 |
| 510k Number | K043419 |
| Device Name: | P&P SAFETY SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | MEDEXEL MEDICAL MFG. CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MEDEXEL MEDICAL MFG. CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-13 |
| Decision Date | 2005-04-15 |
| Summary: | summary |