FDA 510(k) Application Details - K013212

Device Classification Name Media,Coupling,Ultrasound

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510(K) Number K013212
Device Name Media,Coupling,Ultrasound
Applicant NATIONAL THERAPY PRODUCTS INC.
2-191 ROWNTREE DAIRY RD.
WOODBRIDGE, ONTARIO LHL 8B8 CA
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Contact PAUL L HOOEY
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Regulation Number 892.1570

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Classification Product Code MUI
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Date Received 09/25/2001
Decision Date 02/25/2002
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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