Aurora Evacuator

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.

Pre-market Notification Details

Device IDK180372
510k NumberK180372
Device Name:Aurora Evacuator
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Rebound Therapeutics 13900 Alton Parkway, Suite 120 Irvine,  CA  92618
ContactJeffrey J. Valko
CorrespondentJane Metcalf
Rebound Therapeutics 13900 Alton Parkway, Suite 120 Irvine,  CA  92618
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-12
Decision Date2018-04-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860624000431 K180372 000
00860624000424 K180372 000
00860624000417 K180372 000
00850002332087 K180372 000
00850002332070 K180372 000
00850002332063 K180372 000

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