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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 K002405
Device Name SPINAL EPIDURAL NEEDLES
Applicant
Te ME NA S.A.R.L.
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact ART WARD
Correspondent
Te ME NA S.A.R.L.
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact ART WARD
Regulation Number868.5150
Classification Product Code
BSP  
Date Received08/07/2000
Decision Date 06/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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