IS3

Handpiece, Direct Drive, Ac-powered

Hiossen, Inc.

The following data is part of a premarket notification filed by Hiossen, Inc. with the FDA for Is3.

Pre-market Notification Details

Device IDK180527
510k NumberK180527
Device Name:IS3
ClassificationHandpiece, Direct Drive, Ac-powered
Applicant Hiossen, Inc. 85 Ben Fairless Dr. Fairless Hills,  PA  19030
ContactDavid Kim
CorrespondentDavid Kim
Hiossen, Inc. 85 Ben Fairless Dr. Fairless Hills,  PA  19030
Product CodeEKX  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-28
Decision Date2018-05-16
Summary:summary

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