Surgic Pro, Surgic Pro+— 510(k) K173905

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K173905 for Surgic Pro, Surgic Pro+, Substantially Equivalent on 2018-06-19. Applicant: Nakanishi, Inc.. Device class: 1.

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2017-12-22
Decision date: 2018-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanuma-Shi, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.