Device Classification Name |
Catheter, Peritoneal
|
510(k) Number |
K992907 |
Device Name |
INTRADUCER |
Applicant |
TAUT, INC. |
2571 KANEVILLE COURT |
P.O. BOX 326 |
GENEVA,
IL
60134
|
|
Applicant Contact |
RONALD KENSETH |
Correspondent |
TAUT, INC. |
2571 KANEVILLE COURT |
P.O. BOX 326 |
GENEVA,
IL
60134
|
|
Correspondent Contact |
RONALD KENSETH |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 08/30/1999 |
Decision Date | 10/05/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|