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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 K901811
Device Name ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE
Applicant
NEURO TECHNOLOGY
123 WEST MYRNA LN.
TEMPE,  AZ  85284
Applicant Contact COOMBS, MD
Correspondent
NEURO TECHNOLOGY
123 WEST MYRNA LN.
TEMPE,  AZ  85284
Correspondent Contact COOMBS, MD
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/20/1990
Decision Date 05/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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