EPISTAXIS BALLOON CATHETER WITH PACKING— 510(k) K945554

Name: FDA 510(k) clearance K945554
Creator: U.S. Food and Drug Administration
Published: 1995-02-17

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K945554 for EPISTAXIS BALLOON CATHETER WITH PACKING, Substantially Equivalent on 1995-02-17. Applicant: Ultracell Medical Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Ultracell Medical Technologies, Inc.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1994-11-14
Decision date: 1995-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Old Mystic, CT, US

Download summary PDF View on FDA.gov ↗

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