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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, transcutaneous, for pain relief
510(k) Number K812704
Device Name NEUROMED SELECTRA #7720
Applicant
MEDTRONIC VASCULAR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDTRONIC VASCULAR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
NYN  
Date Received09/23/1981
Decision Date 10/19/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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