FDA 510(k) Application Details - K232440

Device Classification Name

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510(K) Number K232440
Device Name Adravision Perio
Applicant Adra Corporation
1673 Mount Paran Rd NW
Atlanta, GA 30327 US
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Contact Yasaman Nematbakhsh
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Regulation Number

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Classification Product Code QIH
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Date Received 08/14/2023
Decision Date 12/05/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K232440


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