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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echoencephalograph
510(k) Number K833522
Device Name NEURO SECTOR FIXATION DEVICE
Applicant
Advanced Technology Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Advanced Technology Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.1240
Classification Product Code
GXW  
Date Received09/19/1983
Decision Date 05/25/1984
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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