TUNGSTEN EYESHIELD— 510(k) K943011

Substantially Equivalent

Medtec, Inc.

FDA 510(k) clearance K943011 for TUNGSTEN EYESHIELD, Substantially Equivalent on 1994-12-23. Applicant: Medtec, Inc.. Device class: 1.

Clearance details

Applicant: Medtec, Inc.
Product code: Code IWS
Device class: Class 1
Regulation: 21 CFR 892.6500
Advisory panel: Radiology
Date received: 1994-06-24
Decision date: 1994-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange City, IA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWS

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K934362 — NUCLEAR ASSOCIATES GLASSERS1993-11-12
K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD1992-05-28

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