The following data is part of a premarket notification filed by Safety Syringes, Inc. with the FDA for Ultrasafe Injection System Needle Guard, Models B50,b100l,b150,b225, And B300.
| Device ID | K972878 |
| 510k Number | K972878 |
| Device Name: | ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 |
| Classification | Syringe, Piston |
| Applicant | SAFETY SYRINGES, INC. 250 W. COLORADO BLVD. SUITE 101 Arcadia, CA 91007 |
| Contact | Anthony Perez |
| Correspondent | Anthony Perez SAFETY SYRINGES, INC. 250 W. COLORADO BLVD. SUITE 101 Arcadia, CA 91007 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-04 |
| Decision Date | 1997-10-30 |
| Summary: | summary |