The following data is part of a premarket notification filed by Medical Solutions, Inc. with the FDA for 8none.
| Device ID | K041839 |
| 510k Number | K041839 |
| Device Name: | 8NONE |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | MEDICAL SOLUTIONS, INC. PO BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith MEDICAL SOLUTIONS, INC. PO BOX 4341 Crofton, MD 21114 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-08 |
| Decision Date | 2005-02-15 |