FDA 510(k) Application Details - K232618

Device Classification Name Endoscope, Neurological

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510(K) Number K232618
Device Name Endoscope, Neurological
Applicant Rebound Therapeutics Corporation
13900 Alton Parkway, Suite 120
Irvine, CA 92618 US
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Contact Timothy Connors
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Regulation Number 882.1480

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Classification Product Code GWG
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Date Received 08/29/2023
Decision Date 10/27/2023
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

FDA Source Information for K232618


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