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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 K150646
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 Received03/12/2015
Decision Date 11/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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