Device Classification Name |
Catheter, Peritoneal, Long-Term Indwelling
|
510(k) Number |
K060897 |
Device Name |
EMBEDDING TOOL, MODEL TE-1000 |
Applicant |
MEDIGROUP, INC. |
14 A STONEHILL RD. |
OSWEGO,
IL
60543
|
|
Applicant Contact |
JOHN A NEVIS |
Correspondent |
MEDIGROUP, INC. |
14 A STONEHILL RD. |
OSWEGO,
IL
60543
|
|
Correspondent Contact |
JOHN A NEVIS |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 04/03/2006 |
Decision Date | 07/18/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|