Cleared Traditional

ULTRACELL NEURO SPONGES

K973083 · Ultracell Medical Technologies, Inc. · Neurology
Dec 1997
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K973083 is an FDA 510(k) clearance for the ULTRACELL NEURO SPONGES, a Neurosurgical Paddie (Class II — Special Controls, product code HBA), submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on December 9, 1997, 113 days after receiving the submission on August 18, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4700.

Submission Details

510(k) Number K973083 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1997
Decision Date December 09, 1997
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HBA — Neurosurgical Paddie
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4700

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