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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K080603
Device Name HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
Applicant
Te ME NA Sas
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
Te ME NA Sas
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number868.5150
Classification Product Code
BSP  
Date Received03/03/2008
Decision Date 08/05/2008
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
Recalls CDRH Recalls
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