The following data is part of a premarket notification filed by Sol-millennium Medical, Inc. with the FDA for Sol-m Blood Collection Needles, Sol-care Safety Blood Collection Needles, Sol-care Safety Blood Collection Needle With Holders, Sol-m Blood Collection Set.
| Device ID | K182146 |
| 510k Number | K182146 |
| Device Name: | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle With Holders, Sol-M Blood Collection Set |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Sol-Millennium Medical, Inc. 1735 North Brown Road, Suite 120 Lawrenceville, GA 30043 |
| Contact | James Barley |
| Correspondent | James Barley Sol-Millennium Medical, Inc. 1735 North Brown Road, Suite 120 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 | 2018-08-08 |
| Decision Date | 2018-12-03 |
| Summary: | summary |