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510(k) K904380

SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM by Custom Medical Concepts, Inc. — Product Code MIA

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 8, 1993
Date Received
September 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Spinal, Short Term
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

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