The following data is part of a premarket notification filed by Medicool, Inc. with the FDA for Insulin Protector.
Device ID | K073555 |
510k Number | K073555 |
Device Name: | INSULIN PROTECTOR |
Classification | Adaptor, Holder, Syringe |
Applicant | MEDICOOL, INC. 20460 GRAMERCY PL. Torrance, CA 90501 |
Contact | Eugene Chang |
Correspondent | Eugene Chang MEDICOOL, INC. 20460 GRAMERCY PL. Torrance, CA 90501 |
Product Code | IQG |
CFR Regulation Number | 890.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-18 |
Decision Date | 2008-07-11 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INSULIN PROTECTOR 74425836 2000514 Live/Registered |
MEDICOOL, INC. 1993-08-17 |