The following data is part of a premarket notification filed by Safety Syringes, Inc. with the FDA for Ultrasafe Passive X-series, Needle Guard Syringe, Piston (accessory).
| Device ID | K011369 |
| 510k Number | K011369 |
| Device Name: | ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) |
| Classification | Syringe, Antistick |
| Applicant | SAFETY SYRINGES, INC. 1925 PALOMAR OAKS WAY, #204 Carlsbad, CA 92008 |
| Contact | Thomas L Hall |
| Correspondent | Thomas L Hall SAFETY SYRINGES, INC. 1925 PALOMAR OAKS WAY, #204 Carlsbad, CA 92008 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-04 |
| Decision Date | 2001-05-29 |