ULTRA HIGH PRESSURE INJECTOR LINES


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K023591
Device Name ULTRA HIGH PRESSURE INJECTOR LINES
Original Applicant
DEROYAL INDUSTRIES, INC.
200 debusk ln.
powell, 
TN 
37849

Original Contact gracie greenway
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 10/25/2002
Decision Date 06/18/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No