Device Classification Name |
catheter, straight
|
510(k) Number |
K072539 |
Device Name |
CURE CATHETER |
Applicant |
CURE MEDICAL LLC. |
28241 CROWN VALLEY PARKWAY |
SUITE 510 |
LAGUNA NIGUEL,
CA
92677
|
|
Applicant Contact |
James Smith |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
CASEY CONRY |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/10/2007 |
Decision Date | 09/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|