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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K952655
Device Name B & L ELECTRODE
Applicant
B & L Engineering
12309 E. Florence Ave.
Santa Fe Springs,  CA  90670
Applicant Contact LEE A BARNES
Correspondent
B & L Engineering
12309 E. Florence Ave.
Santa Fe Springs,  CA  90670
Correspondent Contact LEE A BARNES
Regulation Number890.1375
Classification Product Code
IKN  
Date Received05/08/1995
Decision Date 09/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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