The following data is part of a premarket notification filed by Sol-millennium Medical with the FDA for Sol-care Safety Needle.
| Device ID | K123684 |
| 510k Number | K123684 |
| Device Name: | SOL-CARE SAFETY NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SOL-MILLENNIUM MEDICAL 5415 Sugarloaf Pkwy Ste 2203 Lawrenceville, GA 30043 |
| Contact | Jim Barley |
| Correspondent | Jim Barley SOL-MILLENNIUM MEDICAL 5415 Sugarloaf Pkwy Ste 2203 Lawrenceville, GA 30043 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-30 |
| Decision Date | 2013-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15907996099969 | K123684 | 000 |
| 05907996099955 | K123684 | 000 |