Device Classification Name |
system, evacuator, fluid
|
510(k) Number |
K093479 |
Device Name |
DISPOSABLE SUCTION AND IRRIGATION SYSTEM |
Applicant |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
DONG XING INDUSTRIAL AREA |
KANG LE LU, SHAN XIA DISTRICT |
HENG LI, DONGGUAN, GUANGDONG,
CN
523466
|
|
Applicant Contact |
EUGENE YEUNG |
Correspondent |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
DONG XING INDUSTRIAL AREA |
KANG LE LU, SHAN XIA DISTRICT |
HENG LI, DONGGUAN, GUANGDONG,
CN
523466
|
|
Correspondent Contact |
EUGENE YEUNG |
Regulation Number | 876.4370
|
Classification Product Code |
|
Date Received | 11/09/2009 |
Decision Date | 05/19/2010 |
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
|
|
|