Mizuho Radiolucent Head Frame

FDA 510(k) K955012 · Mizuho America, Inc.

Substantially Equivalent

510(k) numberK955012

Submission

Device name
Mizuho Radiolucent Head Frame
Applicant
Mizuho America, Inc.
Beverly, MA, US
Received
November 1, 1995
Decision date
September 12, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBL – Holder, Head, Neurosurgical (Skull Clamp)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4460
Specialty
Neurology

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Questions and answers

When was Mizuho Radiolucent Head Frame cleared by the FDA?

Mizuho Radiolucent Head Frame (K955012) received a 510(k) decision of Substantially Equivalent on September 12, 1996, 316 days after the submission was received.

What is the product code of K955012?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.