PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

Device Classification Name

set, administration, intravascular

510(k) Number K071421
Device Name PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
Applicant
PROMEPLA
5600 wisconsin avenue
suite 509
chevy chase, 
MD 
20815

Applicant Contact patsy j trisler
Correspondent
PROMEPLA
5600 wisconsin avenue
suite 509
chevy chase, 
MD 
20815

Correspodent Contact patsy j trisler
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 05/22/2007
Decision Date 10/04/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No