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FDA 510(k) Application Details - K051670
Device Classification Name
More FDA Info for this Device
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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