INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S


Device Classification Name

introducer, catheter

510(k) Number K073100
Device Name INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
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 870.1340
Classification Product Code
DYB  
Date Received 11/02/2007
Decision Date 11/30/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls