ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL— 510(k) K823127

Name: FDA 510(k) clearance K823127
Creator: U.S. Food and Drug Administration
Published: 1982-11-29

Substantially Equivalent

Syva Co.

FDA 510(k) clearance K823127 for ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL, Substantially Equivalent on 1982-11-29. Applicant: Syva Co.. Device class: 1.

Clearance details

Applicant: Syva Co.
Product code: Code LAZ
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1982-10-25
Decision date: 1982-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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