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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 K191861
Device Name Aurora Surgiscope System
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 Received07/11/2019
Decision Date 12/06/2019
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
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