Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K002689 |
Device Name |
SWABSITE SWABBABLE VALVE, MODEL 245000 |
Applicant |
QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. |
ALLEN,
TX
75002
|
|
Applicant Contact |
DOUG BRYAN |
Correspondent |
QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. |
ALLEN,
TX
75002
|
|
Correspondent Contact |
DOUG BRYAN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/29/2000 |
Decision Date | 03/06/2001 |
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
|
|
|