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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 K002280
Device Name PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
Applicant
MEDICAL DEVICES, INC.
2500 BELL AVE.
DES MOINES,  IA  50321
Applicant Contact WARREN R WALTERS
Correspondent
MEDICAL DEVICES, INC.
2500 BELL AVE.
DES MOINES,  IA  50321
Correspondent Contact WARREN R WALTERS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/26/2000
Decision Date 02/05/2001
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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