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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 K895662
Device Name DEFIB K-PADS
Applicant
Katecho, Inc.
2601 Bell Ave.
P.O Box 21247
Des Moines,  IA  50315
Applicant Contact LORNE SCHARNBERG
Correspondent
Katecho, Inc.
2601 Bell Ave.
P.O Box 21247
Des Moines,  IA  50315
Correspondent Contact LORNE SCHARNBERG
Regulation Number870.5300
Classification Product Code
LDD  
Date Received09/20/1989
Decision Date 01/18/1990
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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