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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous, intraspinal, short term
510(k) Number K934939
Device Name TEMPORARY SCREENING LEAD/ CATHETER KIT
Applicant
MEDTRONIC VASCULAR
800 53RD AVE., N.E.
MINNEAPOLIS,  MN  55421
Applicant Contact DAVID H MUELLER
Correspondent
MEDTRONIC VASCULAR
800 53RD AVE., N.E.
MINNEAPOLIS,  MN  55421
Correspondent Contact DAVID H MUELLER
Regulation Number868.5120
Classification Product Code
MAJ  
Date Received10/18/1993
Decision Date 05/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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