Device Classification Name |
catheter, peritoneal
|
510(k) Number |
K960426 |
Device Name |
MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER |
Applicant |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
MICHELLE DEMERS |
Correspondent |
MEDICAL COMPONENTS, INC. |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
MICHELLE DEMERS |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 01/29/1996 |
Decision Date | 03/21/1996 |
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
|
|
|