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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 K990519
Device Name PHOENIX EPIDURAL & SPINAL NEEDLES
Applicant
MYCO MEDICAL SUPPLIES, INC.
101 ROSE VALLEY WOODS DR.
CARY,  NC  27513
Applicant Contact SANJIV KUMAR
Correspondent
MYCO MEDICAL SUPPLIES, INC.
101 ROSE VALLEY WOODS DR.
CARY,  NC  27513
Correspondent Contact SANJIV KUMAR
Regulation Number868.5150
Classification Product Code
BSP  
Date Received02/18/1999
Decision Date 06/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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