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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K232618
Device Name Aurora Surgiscope System
Applicant
Rebound Therapeutics Corporation
13900 Alton Pkwy. Suite 120
Irvine,  CA  92618
Applicant Contact Timothy Connors
Correspondent
Rebound Therapeutics Corporation
13900 Alton Pkwy. Suite 120
Irvine,  CA  92618
Correspondent Contact Timothy Connors
Regulation Number882.1480
Classification Product Code
GWG  
Subsequent Product Code
GZT  
Date Received08/29/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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