The following data is part of a premarket notification filed by Sol-milennium Medical, Inc. with the FDA for Sol-m Exchangeable Needles.
| Device ID | K112777 |
| 510k Number | K112777 |
| Device Name: | SOL-M EXCHANGEABLE NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SOL-MILENNIUM MEDICAL, INC. 33822 MALAGA DRIVE Dana Point, CA 92629 |
| Contact | Jim Barley |
| Correspondent | Jim Barley SOL-MILENNIUM MEDICAL, INC. 33822 MALAGA DRIVE Dana Point, CA 92629 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-26 |
| Decision Date | 2012-02-24 |
| Summary: | summary |