INTRODUCER SET, MODEL ADELANTE-S SERIES


Device Classification Name

introducer, catheter

510(k) Number K122084
Device Name INTRODUCER SET, MODEL ADELANTE-S SERIES
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 07/16/2012
Decision Date 08/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized