VARI-SET— 510(k) K894111

Substantially Equivalent

Sonex Medical

FDA 510(k) clearance K894111 for VARI-SET, Substantially Equivalent on 1989-09-28. Applicant: Sonex Medical. Device class: 2.

Clearance details

Applicant: Sonex Medical
Product code: Code LDR
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1989-06-12
Decision date: 1989-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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