Device Classification Name |
Catheter, Peritoneal, Long-Term Indwelling
|
510(k) Number |
K012502 |
Device Name |
MEDIGROUP CATHETER EXTENDER/REPAIR KIT |
Applicant |
JANIN GROUP, INC. |
505 WESTON RIDGE DR. |
NAPERVILLE,
IL
60563 -3932
|
|
Applicant Contact |
JOHN A NAVIS |
Correspondent |
JANIN GROUP, INC. |
505 WESTON RIDGE DR. |
NAPERVILLE,
IL
60563 -3932
|
|
Correspondent Contact |
JOHN A NAVIS |
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 08/03/2001 |
Decision Date | 02/04/2002 |
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
|
|
|