STEELEX ELECTRODE SET


Device Classification Name

electrode, pacemaker, temporary

510(k) Number K030556
Device Name STEELEX ELECTRODE SET
Applicant
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Applicant Contact georg keller
Correspondent
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Correspodent Contact georg keller
Regulation Number 870.3680
Classification Product Code
LDF  
Date Received 02/21/2003
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