FDA 510(k) Application Details - K110500

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

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510(K) Number K110500
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant MACPHERSON MEDICAL, INC.
555 13TH STREET, NW
COLUMBIA SQUARE
WASHINGTON, DC 20004 US
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Contact HOWARD HOLSTEIN
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 02/22/2011
Decision Date 06/23/2011
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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