MODIFICATION TO 30 EXTENSION SET


Device Classification Name

set, administration, intravascular

510(k) Number K021395
Device Name MODIFICATION TO 30 EXTENSION SET
Original Applicant
CHURCHILL MEDICAL SYSTEMS, INC.
87 venture dr.
dover, 
NH 
03820

Original Contact kevin paluch
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 05/02/2002
Decision Date 05/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls