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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 K811452
Device Name BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM
Applicant
Trent Wells, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Trent Wells, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/22/1981
Decision Date 06/02/1981
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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