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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 K201840
Device Name Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
Applicant
Rebound Therapeutics
13900 Alton Pkwy. Suite 120
Irvine,  CA  92618
Applicant Contact Naomi Gong
Correspondent
Rebound Therapeutics
13900 Alton Pkwy. Suite 120
Irvine,  CA  92618
Correspondent Contact Naomi Gong
Regulation Number882.1480
Classification Product Code
GWG  
Subsequent Product Code
GZT  
Date Received07/02/2020
Decision Date 11/04/2020
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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