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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 K921679
Device Name K-DISPERSE
Applicant
KATECHO, INC.
2601 BELL AVE.
P.O BOX 21247
DES MOINES,  IA  50315
Applicant Contact LORNE SCHARNBERG
Correspondent
KATECHO, INC.
2601 BELL AVE.
P.O BOX 21247
DES MOINES,  IA  50315
Correspondent Contact LORNE SCHARNBERG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/08/1992
Decision Date 10/06/1992
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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