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FDA 510(k) Application Details - K170437
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K170437
Device Name
Wrap, Sterilization
Applicant
Andersen Sterilizers,Inc.
3154 Caroline Drive
Haw River, NC 27258 US
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Contact
William K. Andersen
Other 510(k) Applications for this Contact
Regulation Number
880.6850
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Classification Product Code
FRG
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More FDA Info for this Product Code
Date Received
02/13/2017
Decision Date
11/01/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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