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510(k) K923723

SILICONE BRAIN SPATULA SET by Redmond Neurosurgical, Inc. — Product Code HAO

K923723 is an FDA 510(k) premarket notification submitted by Redmond Neurosurgical, Inc. for the device "SILICONE BRAIN SPATULA SET". The FDA issued a decision of Substantially Equivalent on August 12, 1992. The device falls under product code HAO (Instrument, Surgical, Non-Powered), a Class I device regulated under 21 CFR 882.4535.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1992
Date Received
July 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type

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  • K910226 — DURAL DISSECTORS (February 12, 1991)

FDA data resources