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FDA 510(k) Application Details - K990248
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K990248
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
DICOMIT IMAGING SYSTEMS CORP.
75 EAST BEAVER CREEK RD., #9
RICHMOND HILL, ONTARIO L4B 1K6 CA
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Contact
TERRY CALLAHAN
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Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
01/26/1999
Decision Date
04/16/1999
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
N
Expedited Review
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