FDA 510(k) Application Details - K172292

Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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510(K) Number K172292
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant SciCan Ltd.
1440 Don Mills Road
Toronto M3B 3P9 CA
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Contact Teresa Boyce
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 07/31/2017
Decision Date 11/24/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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