The following data is part of a premarket notification filed by 41 Industries Llc with the FDA for Insucozi Insulin Vial Cover.
Device ID | K072174 |
510k Number | K072174 |
Device Name: | INSUCOZI INSULIN VIAL COVER |
Classification | Adaptor, Holder, Syringe |
Applicant | 41 INDUSTRIES LLC 4220 BALSAM STREET Wheat Ridge, CO 80033 |
Contact | Daniel Lafaver |
Correspondent | Daniel Lafaver 41 INDUSTRIES LLC 4220 BALSAM STREET Wheat Ridge, CO 80033 |
Product Code | IQG |
CFR Regulation Number | 890.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-06 |
Decision Date | 2008-01-25 |