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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K896392
Device Name MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717
Applicant
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Applicant Contact WU, RPH
Correspondent
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Correspondent Contact WU, RPH
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received11/06/1989
Decision Date 11/28/1989
Decision Substantially Equivalent (SESE)
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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