Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K082815 |
Device Name |
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS |
Applicant |
WELL LEAD MEDICAL INSTRUMENTS |
A4-1# JINHU INDUSTRIAL ESTATE, |
HUALONG, PAN YU |
GUANGDONG,
CN
511434
|
|
Applicant Contact |
HAN GUANG YUAN |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 09/25/2008 |
Decision Date | 10/08/2008 |
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
|
|
|