Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K032292 |
Device Name |
BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX |
Applicant |
BIOTEQUE CORP. |
3892 SOUTH AMERICA WEST TRAIL |
FLAGGSTAFF,
AZ
86001
|
|
Applicant Contact |
JENNIFER REICH |
Correspondent |
BIOTEQUE CORP. |
3892 SOUTH AMERICA WEST TRAIL |
FLAGGSTAFF,
AZ
86001
|
|
Correspondent Contact |
JENNIFER REICH |
Regulation Number | 880.5200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/24/2003 |
Decision Date | 03/22/2004 |
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
|
|
|