THERMALAP— 510(k) K893212

Substantially Equivalent

O.R. Concepts, Inc.

FDA 510(k) clearance K893212 for THERMALAP, Substantially Equivalent on 1989-06-01. Applicant: O.R. Concepts, Inc.. Device class: 2.

Clearance details

Applicant: O.R. Concepts, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1989-04-27
Decision date: 1989-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, TX, US

Download summary PDF View on FDA.gov ↗

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