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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 K832238
Device Name NEUROMOD COMFORT WAVE #7721 DUAL-
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  
Date Received07/11/1983
Decision Date 08/31/1983
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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