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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20810062430769 | K112777 | 000 |
| 20818392015151 | K112777 | 000 |
| 10818392015147 | K112777 | 000 |
| 10818392015130 | K112777 | 000 |
| 10818392015123 | K112777 | 000 |
| 10818392015116 | K112777 | 000 |
| 10818392015109 | K112777 | 000 |
| 20818392012822 | K112777 | 000 |
| 20818392012754 | K112777 | 000 |
| 20818392012747 | K112777 | 000 |
| 20818392012389 | K112777 | 000 |
| 20818392012372 | K112777 | 000 |
| 10818392010708 | K112777 | 000 |
| 10818392010678 | K112777 | 000 |
| 20818392010668 | K112777 | 000 |
| 10818392015161 | K112777 | 000 |
| 20818392015175 | K112777 | 000 |
| 00840368512520 | K112777 | 000 |
| 20818392016110 | K112777 | 000 |
| 20818392016103 | K112777 | 000 |
| 00818392015751 | K112777 | 000 |
| 20818392015458 | K112777 | 000 |
| 10818392015444 | K112777 | 000 |
| 20818392015281 | K112777 | 000 |
| 10818392015277 | K112777 | 000 |
| 20818392015267 | K112777 | 000 |
| 10818392015246 | K112777 | 000 |
| 10818392015239 | K112777 | 000 |
| 10818392015215 | K112777 | 000 |
| 20818392015205 | K112777 | 000 |
| 20818392015182 | K112777 | 000 |
| 20818392010651 | K112777 | 000 |