Surgical Angle Handpiece, Surgical Straight Handpiece

Handpiece, Rotary Bone Cutting

Nakanishi Inc.

The following data is part of a premarket notification filed by Nakanishi Inc. with the FDA for Surgical Angle Handpiece, Surgical Straight Handpiece.

Pre-market Notification Details

Device IDK171155
510k NumberK171155
Device Name:Surgical Angle Handpiece, Surgical Straight Handpiece
ClassificationHandpiece, Rotary Bone Cutting
Applicant Nakanishi Inc. 700 Shimonhinata Kanuma-shi,  JP 322-8666
ContactKimihiko Satoh
CorrespondentBelia Juarez
Ken Block Consulting 1201 Richardson Dr. Richardson,  TX  75080
Product CodeKMW  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-20
Decision Date2017-11-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560264556294 K171155 000
04560264556287 K171155 000
04560264556270 K171155 000
04560264556263 K171155 000

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