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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K841802
Device Name ELECTRODE CATHETER, ORTHOGONAL TYPE
Applicant
Webster Laboratories, Inc.
P.O. Box 237
Altadena,  CA  91001
Applicant Contact JIM TYBERG
Correspondent
Webster Laboratories, Inc.
P.O. Box 237
Altadena,  CA  91001
Correspondent Contact JIM TYBERG
Regulation Number870.3680
Classification Product Code
LDF  
Date Received05/01/1984
Decision Date 10/18/1984
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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