FDA 510(k) Application Details - K011831

Device Classification Name Apparatus, Suction, Patient Care

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510(K) Number K011831
Device Name Apparatus, Suction, Patient Care
Applicant DENVER BIOMEDICAL, INC.
14998 WEST 6TH AVE., BLDG.E700
GOLDEN, CO 80401 US
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Contact BONNIE VIVIAN
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Regulation Number 870.5050

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Classification Product Code DWM
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Date Received 06/12/2001
Decision Date 06/28/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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