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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 K030556
Device Name STEELEX ELECTRODE SET
Applicant
Aesculap, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact GEORG KELLER
Correspondent
Aesculap, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact GEORG KELLER
Regulation Number870.3680
Classification Product Code
LDF  
Date Received02/21/2003
Decision Date 04/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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