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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 K003228
Device Name K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
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 Received10/16/2000
Decision Date 12/14/2000
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
Recalls CDRH Recalls
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