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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 K943319
Device Name GERTIE MARX EPI-SPINAL TRAY
Applicant
Spinal Specialties, Inc.
4230 Centergate
San Antonio,  TX  78217
Applicant Contact ROBERT KEAHEY
Correspondent
Spinal Specialties, Inc.
4230 Centergate
San Antonio,  TX  78217
Correspondent Contact ROBERT KEAHEY
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received07/11/1994
Decision Date 06/30/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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