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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K170429
Device Name Tyvek Sterilization Pouches with Chevron Seal
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 Number880.6850
Classification Product Code
FRG  
Date Received02/13/2017
Decision Date 10/27/2017
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
Predetermined Change
Control Plan Authorized		 No
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