EDENTRACE MULTI-CHARTER MODEL 3700— 510(k) K883315

Name: FDA 510(k) clearance K883315
Creator: U.S. Food and Drug Administration
Published: 1988-12-28

Substantially Equivalent

Edentec Corp.

FDA 510(k) clearance K883315 for EDENTRACE MULTI-CHARTER MODEL 3700, Substantially Equivalent on 1988-12-28. Applicant: Edentec Corp.. Device class: 1.

Clearance details

Applicant: Edentec Corp.
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1988-08-05
Decision date: 1988-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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