Silicone Brain Spatula Set

FDA 510(k) K923723 · Redmond Neurosurgical, Inc.

Substantially Equivalent

510(k) numberK923723

Submission

Device name
Silicone Brain Spatula Set
Applicant
Redmond Neurosurgical, Inc.
Lake Zurich, IL, US
Received
July 27, 1992
Decision date
August 12, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAO – Instrument, Surgical, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 882.4535
Specialty
Neurology

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Questions and answers

When was Silicone Brain Spatula Set cleared by the FDA?

Silicone Brain Spatula Set (K923723) received a 510(k) decision of Substantially Equivalent on August 12, 1992, 16 days after the submission was received.

What is the product code of K923723?

The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.