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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 K020934
Device Name DR. JAPAN FACIL POINT SPINAL NEEDLE
Applicant
Myco Medical, Inc.
113 Centre W. Ct.
Cary,  NC  27513
Applicant Contact SAM KUMAR
Correspondent
Myco Medical, Inc.
113 Centre W. Ct.
Cary,  NC  27513
Correspondent Contact SAM KUMAR
Regulation Number868.5150
Classification Product Code
BSP  
Date Received03/22/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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