FDA 510(k) Application Details - K130975

Device Classification Name

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510(K) Number K130975
Device Name SWABCAP AND SWABFLUSH
Applicant EXCELSIOR MEDICAL CORP.
555 13TH STREET, NW
WASHINGTON, DC 20004 US
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Contact MICHAEL HEYL
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Regulation Number

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Classification Product Code QBP
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Date Received 04/08/2013
Decision Date 12/24/2013
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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