FDA 510(k) Application Details - K081718

Device Classification Name Bottle, Collection, Vacuum

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510(K) Number K081718
Device Name Bottle, Collection, Vacuum
Applicant ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON, NH 03051 US
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Contact KAREN HALL
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Regulation Number 880.6740

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Classification Product Code KDQ
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Date Received 06/18/2008
Decision Date 07/25/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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