ULTRACELL PACKING WITH SLEEVE— 510(k) K973085

Name: FDA 510(k) clearance K973085
Creator: U.S. Food and Drug Administration
Published: 1997-11-18

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K973085 for ULTRACELL PACKING WITH SLEEVE, Substantially Equivalent on 1997-11-18. 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: 1997-08-18
Decision date: 1997-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Stonington, CT, US

Download summary PDF View on FDA.gov ↗

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