FDA 510(k) Application Details - K983119

Device Classification Name Device, Specimen Collection

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510(K) Number K983119
Device Name Device, Specimen Collection
Applicant HDC CORP.
2109 O'TOOLE AVE.
SAN JOSE, CA 95131 US
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Contact LEN ROSS
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Regulation Number 866.2900

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Classification Product Code LIO
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Date Received 09/08/1998
Decision Date 03/15/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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