The following data is part of a premarket notification filed by Pavel Jordan & Associates, Inc. with the FDA for Count-a-dose.
Device ID | K883311 |
510k Number | K883311 |
Device Name: | COUNT-A-DOSE |
Classification | Syringe, Piston |
Applicant | PAVEL JORDAN & ASSOCIATES, INC. 3001 CHAPEL HILL RD. Orange, CA 92667 |
Contact | Willie Krawitz |
Correspondent | Willie Krawitz PAVEL JORDAN & ASSOCIATES, INC. 3001 CHAPEL HILL RD. Orange, CA 92667 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-05 |
Decision Date | 1988-09-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COUNT-A-DOSE 77966702 3963209 Dead/Cancelled |
PRODIGY DIABETES CARE, LLC 2010-03-23 |
COUNT-A-DOSE 73811676 1588689 Dead/Cancelled |
JORDAN ENTERPRISES 1989-07-10 |