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FDA 510(k) Application Details - K971753
Device Classification Name
Apparatus, Suction, Patient Care
More FDA Info for this Device
510(K) Number
K971753
Device Name
Apparatus, Suction, Patient Care
Applicant
DENVER BIOMATERIALS, INC.
14998 W. 6TH AVE.
BLDG. E700
GOLDEN, CO 80401 US
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Contact
LYNNE LEONARD
Other 510(k) Applications for this Contact
Regulation Number
870.5050
More FDA Info for this Regulation Number
Classification Product Code
DWM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/12/1997
Decision Date
06/27/1997
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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