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FDA 510(k) Application Details - K011831
Device Classification Name
Apparatus, Suction, Patient Care
More FDA Info for this Device
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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More FDA Info for this Product Code
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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