The following data is part of a premarket notification filed by Gas-vak with the FDA for Gas-vak(r) Combination Sterilizer & Ventilator.
Device ID | K902906 |
510k Number | K902906 |
Device Name: | GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR |
Classification | Cabinet, Ethylene-oxide Gas Aerator |
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 | FLI |
CFR Regulation Number | 880.6100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-03 |
Decision Date | 1990-10-15 |