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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K213296
Device Name Anprolene SteriTest RRBI
Applicant
Andersen Sterilizers, Inc.
3154 Caroline Dr.
Haw River,  NC  27258
Applicant Contact William K Andersen
Correspondent
Andersen Sterilizers, Inc.
3154 Caroline Dr.
Haw River,  NC  27258
Correspondent Contact William K Andersen
Regulation Number880.2800
Classification Product Code
FRC  
Date Received10/01/2021
Decision Date 04/12/2022
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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