The following data is part of a premarket notification filed by Collaborativemed, Llc with the FDA for Glucommander Plus.
| Device ID | K061110 |
| 510k Number | K061110 |
| Device Name: | GLUCOMMANDER PLUS |
| Classification | Calculator, Drug Dose |
| Applicant | COLLABORATIVEMED, LLC 14-D PELHAM RIDGE DRIVE Greenville, SC 29615 |
| Contact | Robert Booth |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-20 |
| Decision Date | 2006-06-07 |
| Summary: | summary |