Device Classification Name |
Catheter, Irrigation
|
510(k) Number |
K905422 |
Device Name |
PVC ROUND WOUND DRAINS |
Applicant |
AXIOM MEDICAL, INC. |
7625 ROSECRANS AVE. |
SUITE 29/ P.O. BOX 1306 |
PARAMOUNT,
CA
90723
|
|
Applicant Contact |
MAHENDRA SANGHVI |
Correspondent |
AXIOM MEDICAL, INC. |
7625 ROSECRANS AVE. |
SUITE 29/ P.O. BOX 1306 |
PARAMOUNT,
CA
90723
|
|
Correspondent Contact |
MAHENDRA SANGHVI |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 12/04/1990 |
Decision Date | 02/11/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|