Device Classification Name |
catheter, straight
|
510(k) Number |
K133615 |
Device Name |
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER |
Applicant |
WELL LEAD MEDICAL CO. LTD |
445 APOLLO BEACH BLVD. |
APOLLO BEACH,
FL
33572
|
|
Applicant Contact |
JOHN OBRIEN |
Correspondent |
WELL LEAD MEDICAL CO. LTD |
445 APOLLO BEACH BLVD. |
APOLLO BEACH,
FL
33572
|
|
Correspondent Contact |
JOHN OBRIEN |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 11/25/2013 |
Decision Date | 02/24/2014 |
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
|
|
|