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 |