FDA 510(k) Application Details - K950943

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K950943
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant LECTEC CORP.
10701 RED CIRCLE DR.
MINNETONKA, MN 55343 US
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Contact JULL R KRALL
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 02/16/1995
Decision Date 03/07/1996
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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