TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)


Device Classification Name

electrode, pacemaker, temporary

510(k) Number K072770
Device Name TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
Applicant
Oscor Inc.
3816 de soto blvd.
palm harbor, 
FL 
34683

Applicant Contact mila doskocil
Correspondent
Oscor Inc.
3816 de soto blvd.
palm harbor, 
FL 
34683

Correspodent Contact mila doskocil
Regulation Number 870.3680
Classification Product Code
LDF  
Date Received 09/28/2007
Decision Date 01/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No