Device Classification Name |
Drain, Cervical
|
510(k) Number |
K903989 |
Device Name |
SIL-MED T-TUBE DRAIN |
Applicant |
SIL-MED CORP. |
700 WARNER BLVD. |
TAUNTON,
MA
02780
|
|
Applicant Contact |
WILLIAM S MCCALLUM |
Correspondent |
SIL-MED CORP. |
700 WARNER BLVD. |
TAUNTON,
MA
02780
|
|
Correspondent Contact |
WILLIAM S MCCALLUM |
Regulation Number | 884.3200
|
Classification Product Code |
|
Date Received | 08/29/1990 |
Decision Date | 01/31/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|