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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K950127
Device Name ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY
Applicant
MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS,  MN  55432 -3576
Applicant Contact WILLIAM A FARRELL
Correspondent
MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS,  MN  55432 -3576
Correspondent Contact WILLIAM A FARRELL
Regulation Number882.5880
Classification Product Code
GZB  
Date Received01/12/1995
Decision Date 01/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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