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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sterilizer, ethylene-oxide gas
510(k) Number K192978
Device Name EOGas 4 Ethylene Oxide Gas Sterilizer
Applicant
Andersen Sterilizers, Inc.
3154 Caroline Drive
haw river,  NC  27258
Applicant Contact william k. andersen
Correspondent
Andersen Sterilizers, Inc.
3154 Caroline Drive
haw river,  NC  27258
Correspondent Contact william k. andersen
Regulation Number880.6860
Classification Product Code
FLF  
Date Received10/24/2019
Decision Date 11/12/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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