FDA 510(k) Application Details - K242057

Device Classification Name Generator, Lesion, Radiofrequency

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510(K) Number K242057
Device Name Generator, Lesion, Radiofrequency
Applicant Avanos Medical, Inc.
5405 Windward Parkway
Alpharetta, GA 30004 US
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Contact Liane Miller
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Regulation Number 882.4400

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Classification Product Code GXD
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Date Received 07/15/2024
Decision Date 08/14/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242057


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