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FDA 510(k) Application Details - K993069
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K993069
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE, WI 53201 US
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Contact
ALLEN SCHUH
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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
09/13/1999
Decision Date
09/22/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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