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FDA 510(k) Application Details - K031391
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K031391
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
OPHTHALMIC TECHNOLOGIES, INC.
377 RT 17 S
HASBROUCK HEIGHTS, NJ 07604 US
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Contact
GEORGE MYERS
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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
05/02/2003
Decision Date
06/20/2003
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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