The following data is part of a premarket notification filed by Gas-vak with the FDA for Gas-vak(r), Model 300.
Device ID | K890438 |
510k Number | K890438 |
Device Name: | GAS-VAK(R), MODEL 300 |
Classification | Apparatus, Gas-scavenging |
Applicant | GAS-VAK P.O. BOX 941 Westwood, CA 96137 |
Contact | John D Kight |
Correspondent | John D Kight GAS-VAK P.O. BOX 941 Westwood, CA 96137 |
Product Code | CBN |
CFR Regulation Number | 868.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-31 |
Decision Date | 1989-08-07 |