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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated External Defibrillators (Non-Wearable)
510(k) Number K002806
Device Name K-DEFIB/PACE, MODEL KDP-60A
Applicant
Katecho, Inc.
2500 Bell Ave.
P.O. Box 21247
Des Moines,  IA  50321
Applicant Contact WARREN R WALTERS
Correspondent
Katecho, Inc.
2500 Bell Ave.
P.O. Box 21247
Des Moines,  IA  50321
Correspondent Contact WARREN R WALTERS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/08/2000
Decision Date 11/21/2000
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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