Device Classification Name |
set, i.v. fluid transfer
|
510(k) Number |
K022523 |
Device Name |
RAPID-FILL TUBESET, MODEL 90005 |
Applicant |
BAXA CORP. |
13760 EAST ARAPAHOE RD. |
ENGLEWOOD,
CO
80112 -3903
|
|
Applicant Contact |
KARL STEINBECK |
Correspondent |
BAXA CORP. |
13760 EAST ARAPAHOE RD. |
ENGLEWOOD,
CO
80112 -3903
|
|
Correspondent Contact |
KARL STEINBECK |
Regulation Number | 880.5440
|
Classification Product Code |
|
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
|
|
|