EXPANDACEL NASAL TAMPONS, MODIFICATION— 510(k) K912524

Name: FDA 510(k) clearance K912524
Creator: U.S. Food and Drug Administration
Published: 1991-08-15

Substantially Equivalent

Surgitrend, Ltd.

FDA 510(k) clearance K912524 for EXPANDACEL NASAL TAMPONS, MODIFICATION, Substantially Equivalent on 1991-08-15. Applicant: Surgitrend, Ltd.. Device class: 1.

Clearance details

Applicant: Surgitrend, Ltd.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1991-06-03
Decision date: 1991-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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