D.O.R.C. MICRODIATHERMY SYSTEM— 510(k) K962135

Name: FDA 510(k) clearance K962135
Creator: U.S. Food and Drug Administration
Published: 1996-08-29

Substantially Equivalent

Dutch Ophthalmic USA, Inc.

FDA 510(k) clearance K962135 for D.O.R.C. MICRODIATHERMY SYSTEM, Substantially Equivalent on 1996-08-29. Applicant: Dutch Ophthalmic USA, Inc.. Device class: 2.

Clearance details

Applicant: Dutch Ophthalmic USA, Inc.
Product code: Code HQO
Device class: Class 2
Regulation: 21 CFR 886.4115
Advisory panel: Ophthalmic
Date received: 1996-06-03
Decision date: 1996-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, NH, 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.