The following data is part of a premarket notification filed by Fortunique Medical Products with the FDA for Cg Disposable Syringe.
| Device ID | K944920 |
| 510k Number | K944920 |
| Device Name: | CG DISPOSABLE SYRINGE |
| Classification | Syringe, Piston |
| Applicant | FORTUNIQUE MEDICAL PRODUCTS 28TH FLOOR, UBN TOWER, NO. 10 JALAN P. RAMLEE Kuala Lumpur, MY 50250 |
| Contact | Charles M Hubbs |
| Correspondent | Charles M Hubbs FORTUNIQUE MEDICAL PRODUCTS 28TH FLOOR, UBN TOWER, NO. 10 JALAN P. RAMLEE Kuala Lumpur, MY 50250 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-06 |
| Decision Date | 1994-12-20 |