GISH TUBING AND CONNECTORS WITH GBS COATING


Device Classification Name

adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

510(k) Number K030077
Device Name GISH TUBING AND CONNECTORS WITH GBS COATING
Original Applicant
GISH BIOMEDICAL, INC.
11874 south evelyn circle
houston, 
TX 
77071

Original Contact j. harvey knauss
Regulation Number 870.4290
Classification Product Code
DTL  
Subsequent Product Code
DWF  
Date Received 01/08/2003
Decision Date 03/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No