FDA 510(k) Application Details - K051670

Device Classification Name

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510(K) Number K051670
Device Name RF TUNNELER WIRE
Applicant BAYLIS MEDICAL CO., INC.
2580 MATHESON BLVD. E
MISSISSAUGA, ONTARIO L4W 4J1 CA
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Contact MEGHAL KHAKHAR
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Regulation Number

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Classification Product Code PDU
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Date Received 06/22/2005
Decision Date 03/30/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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