LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS— 510(k) K091598

Name: FDA 510(k) clearance K091598
Creator: U.S. Food and Drug Administration
Published: 2009-06-29

Substantially Equivalent

Nucletron Corp.

FDA 510(k) clearance K091598 for LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS, Substantially Equivalent on 2009-06-29. Applicant: Nucletron Corp.. Device class: 2.

Clearance details

Applicant: Nucletron Corp.
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2009-06-03
Decision date: 2009-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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