FDA 510(k) Application Details - K994344

Device Classification Name Probe, Radiofrequency Lesion

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510(K) Number K994344
Device Name Probe, Radiofrequency Lesion
Applicant ROCKET MEDICAL PLC
FACTORIES 3 & 4,
WEAR INDUSTRIAL ESTATE
WASHINGTON, TYNE & WEAR NE37 1NE GB
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Contact LES TODD
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Regulation Number 882.4725

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Classification Product Code GXI
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Date Received 12/22/1999
Decision Date 03/21/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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