Device Classification Name |
Needle, Fistula
|
510(k) Number |
K832136 |
Device Name |
DUAL FLOW NEEDLE |
Applicant |
TRAVENOL LABORATORIES, S.A. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
TRAVENOL LABORATORIES, S.A. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 07/01/1983 |
Decision Date | 10/14/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|