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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Spinal, Short Term
510(k) Number K904380
Device Name SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM
Applicant
Custom Medical Concepts, Inc.
26 High St.
Chelmsford,  MA  01824
Applicant Contact EDWARD MCNAMARA
Correspondent
Custom Medical Concepts, Inc.
26 High St.
Chelmsford,  MA  01824
Correspondent Contact EDWARD MCNAMARA
Regulation Number868.5150
Classification Product Code
MIA  
Date Received09/26/1990
Decision Date 04/08/1993
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
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