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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K935083
Device Name PEDIATRIC DEFIB K-PADS
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 Number870.5300
Classification Product Code
LDD  
Date Received10/25/1993
Decision Date 07/25/1994
Decision SE SUBJECT TO TRACKING REG (ST)
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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