The following data is part of a premarket notification filed by Safety Syringes, Inc. with the FDA for Ultrasafe Passive Needle Guard.
| Device ID | K122558 |
| 510k Number | K122558 |
| Device Name: | ULTRASAFE PASSIVE NEEDLE GUARD |
| Classification | Syringe, Antistick |
| Applicant | SAFETY SYRINGES, INC. 2875 Loker Ave E Carlsbad, CA 92010 |
| Contact | Suzanne Richardson |
| Correspondent | Suzanne Richardson SAFETY SYRINGES, INC. 2875 Loker Ave E Carlsbad, CA 92010 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-22 |
| Decision Date | 2012-09-20 |
| Summary: | summary |