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FDA 510(k) Application Details - K052436
Device Classification Name
Apparatus, Suction, Patient Care
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510(K) Number
K052436
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
JEFF HILL
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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
09/06/2005
Decision Date
10/06/2005
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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