RAPID-FILL TUBESET, MODEL 90005


Device Classification Name

set, i.v. fluid transfer

510(k) Number K022523
Device Name RAPID-FILL TUBESET, MODEL 90005
Original Applicant
BAXA CORP.
13760 east arapahoe rd.
englewood, 
CO 
80112 -3903

Original Contact karl steinbeck
Regulation Number 880.5440
Classification Product Code
LHI  
Date Received 07/30/2002
Decision Date 08/12/2002
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