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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K203745
Device Name AURORA Evacuator +Coag
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 Number878.4400
Classification Product Code
GEI  
Date Received12/22/2020
Decision Date 12/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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