MODIFICATION TO BIOTRONIK’S STERILIZATION PROCESS


Device Classification Name

permanent pacemaker electrode

510(k) Number K023803
Device Name MODIFICATION TO BIOTRONIK’S STERILIZATION PROCESS
Original Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, 
OR 
97035

Original Contact jon brumbaugh
Regulation Number 870.3680
Classification Product Code
DTB  
Date Received 11/14/2002
Decision Date 12/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No