Device Classification Name |
Catheter, Straight
|
510(k) Number |
K110653 |
Device Name |
CURE CATHETER |
Applicant |
CURE MEDICAL LLC. |
3722 AVENUE SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
ROBYN SCOPIS |
Correspondent |
CURE MEDICAL LLC. |
3722 AVENUE SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
ROBYN SCOPIS |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 03/07/2011 |
Decision Date | 08/01/2011 |
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
|
Recalls |
CDRH Recalls
|
|
|