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FDA 510(k) Application Details - K242057
Device Classification Name
Generator, Lesion, Radiofrequency
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
882.4400
More FDA Info for this Regulation Number
Classification Product Code
GXD
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More FDA Info for this Product Code
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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