ULTRACELL NEURO SPONGES— 510(k) K950647

Name: FDA 510(k) clearance K950647
Creator: U.S. Food and Drug Administration
Published: 1995-08-15

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K950647 for ULTRACELL NEURO SPONGES, Substantially Equivalent on 1995-08-15. 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: 1995-02-13
Decision date: 1995-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Old Mystic, 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.