EYE BARRIER— 510(k) K863182

Substantially Equivalent

O.R. Concepts, Inc.

FDA 510(k) clearance K863182 for EYE BARRIER, Substantially Equivalent on 1986-09-03. Applicant: O.R. Concepts, Inc.. Device class: 1.

Clearance details

Applicant: O.R. Concepts, Inc.
Product code: Code HQZ
Device class: Class 1
Regulation: 21 CFR 886.5842
Advisory panel: Ophthalmic
Date received: 1986-08-19
Decision date: 1986-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQZ

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K945392 — SPECTACLE FRAME1994-12-15
K945770 — OPTICAL FRAMES1994-12-15

More clearances from O.R. Concepts, Inc.

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K935971 — FLOWGUN ELECTROCAUTERY PROBES1994-05-16
K935645 — FLOWGUN REUSABLE IRRIGATION PROBES1994-03-07
K926242 — ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE1993-10-15

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