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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Non-Powered
510(k) Number K923723
Device Name SILICONE BRAIN SPATULA SET
Applicant
Redmond Neurosurgical, Inc.
250 Telser Rd.
Unit E
Lake Zurich,  IL  60047
Applicant Contact JOHN A REDMOND
Correspondent
Redmond Neurosurgical, Inc.
250 Telser Rd.
Unit E
Lake Zurich,  IL  60047
Correspondent Contact JOHN A REDMOND
Regulation Number882.4535
Classification Product Code
HAO  
Date Received07/27/1992
Decision Date 08/12/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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