T-8000 THEROZONE UNIT— 510(k) K141504

Substantially Equivalent

Therozone USA, Inc.

FDA 510(k) clearance K141504 for T-8000 THEROZONE UNIT, Substantially Equivalent on 2015-02-24. Applicant: Therozone USA, Inc.. Device class: 1.

Clearance details

Applicant
Therozone USA, Inc.
Product code
Code EIA
Device class
Class 1
Regulation
21 CFR 872.6640
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Monica, CA, US
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