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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K915328
Device Name GEL-TAC
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 Number870.5550
Classification Product Code
DRO  
Date Received11/26/1991
Decision Date 06/29/1992
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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