FDA 510(k) Application Details - K973074

Device Classification Name Chromatography (Liquid, Gel), Clinical Use

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510(K) Number K973074
Device Name Chromatography (Liquid, Gel), Clinical Use
Applicant WATERS CORPORATION
34 MAPLE ST.
MILFORD, MA 01757-3696 US
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Contact VIRGINIA L CORBIN
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Regulation Number 862.2260

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Classification Product Code KZR
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Date Received 08/18/1997
Decision Date 10/06/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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