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FDA 510(k) Application Details - K042831
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K042831
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
REICHERT INC.
3374 WALDEN AVE.
DEPEW, NY 14043 US
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Contact
FRANK J DREXELIUS
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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
10/13/2004
Decision Date
10/28/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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