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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K060186
Device Name POLYPLEX STIMULATING CATHETER SYSTEM
Applicant
Te ME NA Sas
962 Allegro Lane
Apollo Beach,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
Te ME NA Sas
962 Allegro Lane
Apollo Beach,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received01/24/2006
Decision Date 07/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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