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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 K950820
Device Name SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE
Applicant
Spinal Specialties, Inc.
4230 Centergate
San Antonio,  TX  78217
Applicant Contact MICHAEL WAKELY
Correspondent
Spinal Specialties, Inc.
4230 Centergate
San Antonio,  TX  78217
Correspondent Contact MICHAEL WAKELY
Regulation Number868.5150
Classification Product Code
BSP  
Date Received02/23/1995
Decision Date 06/30/1995
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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