The following data is part of a premarket notification filed by Hmi Industries, Inc. with the FDA for Preci-jet 50.
Device ID | K921797 |
510k Number | K921797 |
Device Name: | PRECI-JET 50 |
Classification | Injector, Fluid, Non-electrically Powered |
Applicant | HMI INDUSTRIES, INC. 34 GREENSBORO DR. 2ND FLOOR Rexdale, Ontario, CA M9w 1e1 |
Contact | Stevenson |
Correspondent | Stevenson HMI INDUSTRIES, INC. 34 GREENSBORO DR. 2ND FLOOR Rexdale, Ontario, CA M9w 1e1 |
Product Code | KZE |
CFR Regulation Number | 880.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-14 |
Decision Date | 1992-11-17 |