FDA 510(k) Application Details - K020354

Device Classification Name Generator, Lesion, Radiofrequency

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510(K) Number K020354
Device Name Generator, Lesion, Radiofrequency
Applicant BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO L4W-4T7 CA
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Contact KRIS SHAH
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Regulation Number 882.4400

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Classification Product Code GXD
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Date Received 02/04/2002
Decision Date 05/03/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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