PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR


Device Classification Name

pacemaker lead adaptor

510(k) Number K024156
Device Name PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
Original Applicant
Oscor Inc.
3816 de soto blvd.
palm harbor, 
FL 
34683

Original Contact mila doskocil
Regulation Number 870.3620
Classification Product Code
DTD  
Date Received 12/17/2002
Decision Date 01/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No