Cleared Traditional

MIZUHO RADIOLUCENT HEAD FRAME

K955012 · Mizuho America, Inc. · Neurology
Sep 1996
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K955012 is an FDA 510(k) clearance for the MIZUHO RADIOLUCENT HEAD FRAME, a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Mizuho America, Inc. (Beverly, US). The FDA issued a Cleared decision on September 12, 1996, 316 days after receiving the submission on November 1, 1995. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K955012 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1995
Decision Date September 12, 1996
Days to Decision 316 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBL — Holder, Head, Neurosurgical (skull Clamp)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4460

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