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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 K891992
Device Name TENZCARE STIMULATOR 6890
Applicant
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
cottae grove,  MN  55016
Applicant Contact jacquelyn d bush
Correspondent
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
cottae grove,  MN  55016
Correspondent Contact jacquelyn d bush
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/28/1989
Decision Date 10/12/1989
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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