TRI AUTO ZX— 510(k) K970339

Substantially Equivalent

J. Morita USA, Inc.

FDA 510(k) clearance K970339 for TRI AUTO ZX, Substantially Equivalent on 1997-06-04. Applicant: J. Morita USA, Inc.. Device class: 1.

Clearance details

Applicant
J. Morita USA, Inc.
Product code
Code EKX
Device class
Class 1
Regulation
21 CFR 872.4200
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
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