AURORA Evacuator +Coag

Electrosurgical, Cutting & Coagulation & Accessories

Rebound Therapeutics

The following data is part of a premarket notification filed by Rebound Therapeutics with the FDA for Aurora Evacuator +coag.

Pre-market Notification Details

Device IDK203745
510k NumberK203745
Device Name:AURORA Evacuator +Coag
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Rebound Therapeutics 13900 Alton Pkwy Suite 120 Irvine,  CA  92618
ContactNaomi Gong
CorrespondentNaomi Gong
Rebound Therapeutics 13900 Alton Pkwy Suite 120 Irvine,  CA  92618
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-22
Decision Date2021-12-02

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