ORS-111— 510(k) K953654

Substantially Equivalent

O.R. Solutions, Inc.

FDA 510(k) clearance K953654 for ORS-111, Substantially Equivalent on 1995-09-22. Applicant: O.R. Solutions, Inc.. Device class: 2.

Clearance details

Applicant: O.R. Solutions, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1995-08-02
Decision date: 1995-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from O.R. Solutions, Inc.

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K021288 — ORS-1000LD2002-06-27
K021289 — WARMER 2000LD2002-06-26

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