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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cabinet, Ethylene-Oxide Gas Aerator
510(k) Number K902906
Device Name GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR
Applicant
Gas-Vak
P.O. Box 941
Westwood,  CA  96137
Applicant Contact JOHN D KIGHT
Correspondent
Gas-Vak
P.O. Box 941
Westwood,  CA  96137
Correspondent Contact JOHN D KIGHT
Regulation Number880.6100
Classification Product Code
FLI  
Date Received07/03/1990
Decision Date 10/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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