ULTRACELL NEURO SPONGES— 510(k) K973083

Name: FDA 510(k) clearance K973083
Creator: U.S. Food and Drug Administration
Published: 1997-12-09

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K973083 for ULTRACELL NEURO SPONGES, Substantially Equivalent on 1997-12-09. Applicant: Ultracell Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ultracell Medical Technologies, Inc.
Product code: Code HBA
Device class: Class 2
Regulation: 21 CFR 882.4700
Advisory panel: Neurology
Date received: 1997-08-18
Decision date: 1997-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Stonington, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.