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FDA 510(k) Application Details - K023082
Device Classification Name
Monitor, Blood-Flow, Ultrasonic
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510(K) Number
K023082
Device Name
Monitor, Blood-Flow, Ultrasonic
Applicant
BIONET COMPANY LTD
1308 MORNINGSIDE PARK DR.
ALPHARETTA, GA 30022 US
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Contact
JAY MANSOUR
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Regulation Number
884.2660
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Classification Product Code
HEP
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More FDA Info for this Product Code
Date Received
09/17/2002
Decision Date
03/03/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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