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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K894387
Device Name WESTCO MADAYAG PAB NEEDLE
Applicant
Western Medical, Ltd.
7079 Mission Gorge Rd.
Bldg. J
San Diego,  CA  92120
Applicant Contact WADE G GILLILAND,JR
Correspondent
Western Medical, Ltd.
7079 Mission Gorge Rd.
Bldg. J
San Diego,  CA  92120
Correspondent Contact WADE G GILLILAND,JR
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/17/1989
Decision Date 11/07/1989
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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