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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K003896
Device Name LYMPHA VISION-EXPERT
Applicant
Bexley Trading, Inc.
1105 Buckbrush Dr.
Folsom,  CA  95630
Applicant Contact MICHAEL ZMUDA
Correspondent
Bexley Trading, Inc.
1105 Buckbrush Dr.
Folsom,  CA  95630
Correspondent Contact MICHAEL ZMUDA
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IPF  
Date Received12/18/2000
Decision Date 04/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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