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FDA 510(k) Application Details - K023024
Device Classification Name
Transducer, Ultrasonic, Diagnostic
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510(K) Number
K023024
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
VASCULAR CONTROL SYSTEMS, INC
32236- E PASEO ADELANTO
SAN JUAN CAPISTRANO, CA 92675 US
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Contact
AL MEMMOLO
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Regulation Number
892.1570
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Classification Product Code
ITX
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More FDA Info for this Product Code
Date Received
09/11/2002
Decision Date
09/26/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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