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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 K881356
Device Name EXTERNAL PACEMAKER WIRE DRESSING CHANGE
Applicant
Neal & Assoc., Inc.
6005 N. Gregory Dr.
Columbia,  MO  65202
Applicant Contact CAROL NEAL
Correspondent
Neal & Assoc., Inc.
6005 N. Gregory Dr.
Columbia,  MO  65202
Correspondent Contact CAROL NEAL
Regulation Number870.3680
Classification Product Code
LDF  
Date Received03/28/1988
Decision Date 05/19/1988
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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