The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for Examix Dispenser.
Device ID | K880849 |
510k Number | K880849 |
Device Name: | EXAMIX DISPENSER |
Classification | Burnisher, Operative |
Applicant | G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale, AZ 85260 |
Contact | Donald A Mckenzie |
Correspondent | Donald A Mckenzie G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale, AZ 85260 |
Product Code | EKJ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-01 |
Decision Date | 1988-05-11 |