Device Classification Name |
catheter, irrigation
|
510(k) Number |
K926496 |
Device Name |
SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN |
Applicant |
SIL-MED CORP. |
700 WARNER BLVD. |
TAUNTON,
MA
02780
|
|
Applicant Contact |
KAREN K SYLVIA |
Correspondent |
SIL-MED CORP. |
700 WARNER BLVD. |
TAUNTON,
MA
02780
|
|
Correspondent Contact |
KAREN K SYLVIA |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 12/29/1992 |
Decision Date | 05/24/1995 |
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
|