PREPARE ADMINISTRATION SET


Device Classification Name

set, administration, intravascular

510(k) Number K023769
Device Name PREPARE ADMINISTRATION SET
Original Applicant
APPRO HEALTHCARE, INC.
847 main st.
buffalo, 
NY 
14203

Original Contact john r semler
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 11/12/2002
Decision Date 12/30/2002
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