EXPANDACELL NASAL PACK WITH AIRWAY— 510(k) K950024

Name: FDA 510(k) clearance K950024
Creator: U.S. Food and Drug Administration
Published: 1995-02-17

Substantially Equivalent

Shippert Medical Technologies Corp.

FDA 510(k) clearance K950024 for EXPANDACELL NASAL PACK WITH AIRWAY, Substantially Equivalent on 1995-02-17. Applicant: Shippert Medical Technologies Corp.. Device class: 1.

Clearance details

Applicant: Shippert Medical Technologies Corp.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1995-01-04
Decision date: 1995-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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