FLEX-LOOP FLEXIBLE EAR CORETTE— 510(k) K852039

Substantially Equivalent

Bionix Corp.

FDA 510(k) clearance K852039 for FLEX-LOOP FLEXIBLE EAR CORETTE, Substantially Equivalent on 1985-06-11. Applicant: Bionix Corp.. Device class: 1.

Clearance details

Applicant: Bionix Corp.
Product code: Code JYG
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 1985-05-09
Decision date: 1985-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holland, OH, US

Download summary PDF View on FDA.gov ↗

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