Device Classification Name |
Catheter, Peritoneal, Long-Term Indwelling
|
510(k) Number |
K071167 |
Device Name |
FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 |
Applicant |
MEDIGROUP, INC. |
14 A STONEHILL RD. |
OSWEGO,
IL
60543 -9400
|
|
Applicant Contact |
JOHN A NAVIS |
Correspondent |
MEDIGROUP, INC. |
14 A STONEHILL RD. |
OSWEGO,
IL
60543 -9400
|
|
Correspondent Contact |
JOHN A NAVIS |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 04/26/2007 |
Decision Date | 08/31/2007 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|