The following data is part of a premarket notification filed by Sol-millennium Medical, Inc. with the FDA for Sol-m Insulin Syringe, Sol-m Tb Syringe.
| Device ID | K153537 |
| 510k Number | K153537 |
| Device Name: | Sol-M Insulin Syringe, Sol-M TB Syringe |
| Classification | Syringe, Piston |
| Applicant | SOL-MILLENNIUM MEDICAL, INC. 1735 North Brown Road, Suite 100 Lawrenceville, GA 30043 |
| Contact | Jim Barley |
| Correspondent | Jim Barley SOL-MILLENNIUM MEDICAL, INC. 1735 North Brown Road, Suite 100 Lawrenceville, GA 30043 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-10 |
| Decision Date | 2016-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10015482263161 | K153537 | 000 |
| 10015482263154 | K153537 | 000 |
| 10015482263147 | K153537 | 000 |
| 10015482263130 | K153537 | 000 |
| 10015482263123 | K153537 | 000 |
| 10015482263116 | K153537 | 000 |
| 10015482263055 | K153537 | 000 |
| 10015482263031 | K153537 | 000 |