FDA 510(k) Application Details - K961757

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K961757
Device Name Transducer, Ultrasonic, Diagnostic
Applicant ECO-MED PHARMACEUTICALS, INC.
6155 TOMKEN ROAD
UNIT 13
MISSISSAUGA, ONTARIO L4W 1H3 CA
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Contact PAUL L HOOEY
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 05/06/1996
Decision Date 07/25/1996
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 N
Expedited Review



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