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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K900997
Device Name K-STERILE TENS ELECTRODES
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 Number882.1320
Classification Product Code
GXY  
Date Received03/02/1990
Decision Date 03/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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