The following data is part of a premarket notification filed by Dolomite Biotech Sdn Bhd with the FDA for Ssafe Plus Disposable Safety Syringe, 3 Cc And 5 Cc.
| Device ID | K070117 |
| 510k Number | K070117 |
| Device Name: | SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC |
| Classification | Syringe, Antistick |
| Applicant | DOLOMITE BIOTECH SDN BHD 417 WHITNEY STREET San Leandro, CA 94577 |
| Contact | Timothy Liew |
| Correspondent | Timothy Liew DOLOMITE BIOTECH SDN BHD 417 WHITNEY STREET San Leandro, CA 94577 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-12 |
| Decision Date | 2007-08-06 |
| Summary: | summary |