PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB


Device Classification Name

permanent pacemaker electrode

510(k) Number K024053
Device Name PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
Original Applicant
Oscor Inc.
3816 de soto blvd.
palm harbor, 
FL 
34683

Original Contact mila doskocil
Regulation Number 870.3680
Classification Product Code
DTB  
Date Received 12/09/2002
Decision Date 01/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No