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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 K942863
Device Name EPIDURAL NEEDLE
Applicant
Spinal Specialties, Inc.
4230 Centergate
San Antonio,  TX  78217
Applicant Contact ROBERT KEAHNEY
Correspondent
Spinal Specialties, Inc.
4230 Centergate
San Antonio,  TX  78217
Correspondent Contact ROBERT KEAHNEY
Regulation Number868.5150
Classification Product Code
BSP  
Date Received06/17/1994
Decision Date 08/11/1995
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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