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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K900740
Device Name SPECIMEX DC
Applicant
Soredex Medical Systems
200 Beach Airport Rd.
Rte. 21, Box 200
Conroe,  TX  77301
Applicant Contact JOHN R HOGAN
Correspondent
Soredex Medical Systems
200 Beach Airport Rd.
Rte. 21, Box 200
Conroe,  TX  77301
Correspondent Contact JOHN R HOGAN
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received02/16/1990
Decision Date 05/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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