The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Applicator Nozzle.
Device ID | K926368 |
510k Number | K926368 |
Device Name: | APPLICATOR NOZZLE |
Classification | Burnisher, Operative |
Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
Contact | John Discko |
Correspondent | John Discko CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
Product Code | EKJ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-22 |
Decision Date | 1993-09-15 |