The following data is part of a premarket notification filed by Sol-millennium Medical, Inc. with the FDA for Sol-care Safety Blood Collection Needle With And Without Pre-attached Holder.
| Device ID | K163073 |
| 510k Number | K163073 |
| Device Name: | Sol-Care Safety Blood Collection Needle With And Without Pre-Attached Holder |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Sol-Millennium Medical, Inc. 1735 North Brown Road, Suite 120 Lawrenceville, GA 30043 |
| Contact | Jim Barley |
| Correspondent | Jim Barley Sol-Millennium Medical, Inc. 1735 North Brown Road, Suite 120 Lawrenceville, GA 30043 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-02 |
| Decision Date | 2017-05-19 |
| Summary: | summary |