FOGLESS— 510(k) K923843

Substantially Equivalent

Sorex Medical

FDA 510(k) clearance K923843 for FOGLESS, Substantially Equivalent on 1994-03-25. Applicant: Sorex Medical. Device class: 2.

Clearance details

Applicant: Sorex Medical
Product code: Code OCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1992-07-31
Decision date: 1994-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.