The following data is part of a premarket notification filed by Spectrum Biotech, Inc. with the FDA for Solo-safe Safety Syringe, Size-3cc.
| Device ID | K003555 |
| 510k Number | K003555 |
| Device Name: | SOLO-SAFE SAFETY SYRINGE, SIZE-3CC |
| Classification | Syringe, Antistick |
| Applicant | SPECTRUM BIOTECH, INC. 821 EAST 17TH ST. N.vancouver, British Columbia, CA V7l 2x2 |
| Contact | Ian Mcdougall |
| Correspondent | Ian Mcdougall SPECTRUM BIOTECH, INC. 821 EAST 17TH ST. N.vancouver, British Columbia, CA V7l 2x2 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-17 |
| Decision Date | 2001-08-29 |