The following data is part of a premarket notification filed by Safety Syringes, Inc. with the FDA for Ultrasafe Aspirating Syringe.
| Device ID | K944425 |
| 510k Number | K944425 |
| Device Name: | ULTRASAFE ASPIRATING SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | SAFETY SYRINGES, INC. 250 W. COLORADO BLVD. SUITE 101 Arcadia, CA 91007 |
| Contact | J. R Firth |
| Correspondent | J. R Firth SAFETY SYRINGES, INC. 250 W. COLORADO BLVD. SUITE 101 Arcadia, CA 91007 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-12 |
| Decision Date | 1995-01-26 |