HYDRO-SIL(TM) COATED GUIDEWIRES— 510(k) K900822

Name: FDA 510(k) clearance K900822
Creator: U.S. Food and Drug Administration
Published: 1990-07-17

Substantially Equivalent

National-Standard Medical Products

FDA 510(k) clearance K900822 for HYDRO-SIL(TM) COATED GUIDEWIRES, Substantially Equivalent on 1990-07-17. Applicant: National-Standard Medical Products. Device class: 2.

Clearance details

Applicant: National-Standard Medical Products
Product code: Code DOX
Device class: Class 2
Regulation: 21 CFR 862.3550
Advisory panel: Clinical Toxicology
Date received: 1990-02-21
Decision date: 1990-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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