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FDA 510(k) Application Details - K162042
Device Classification Name
Pump, Infusion, Analytical Sampling
More FDA Info for this Device
510(K) Number
K162042
Device Name
Pump, Infusion, Analytical Sampling
Applicant
OPTISCAN BIOMEDICAL CORP.
24590 CLAWITER ROAD
HAYWARD, CA 94545 US
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Contact
DON WEBBER
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Regulation Number
880.5725
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Classification Product Code
LZF
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More FDA Info for this Product Code
Date Received
07/25/2016
Decision Date
10/16/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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