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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K940586
Device Name K-SNAP
Applicant
Katecho, Inc.
2500 Bell Ave.
P.O. Box 21247
Des Moines,  IA  50321
Applicant Contact LORNE SCHARNBERG
Correspondent
Katecho, Inc.
2500 Bell Ave.
P.O. Box 21247
Des Moines,  IA  50321
Correspondent Contact LORNE SCHARNBERG
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/08/1994
Decision Date 06/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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