Device Classification Name |
Catheter, Peritoneal
|
510(k) Number |
K942709 |
Device Name |
MEDIASTINAL SILICONE DRAINS |
Applicant |
SIL-MED CORP. |
700 WARNER BLVD. |
TAUNTON,
MA
02780
|
|
Applicant Contact |
KAREN SYLVIA |
Correspondent |
SIL-MED CORP. |
700 WARNER BLVD. |
TAUNTON,
MA
02780
|
|
Correspondent Contact |
KAREN SYLVIA |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 06/08/1994 |
Decision Date | 01/04/1996 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|