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510(k) K093479

Device
DISPOSABLE SUCTION AND IRRIGATION SYSTEM
Applicant
MODERN MEDICAL EQUIPMENT MFG., LTD.
510(k) number
K093479
Product code
FHF  
Decision
Substantially Equivalent (SESE)
Decision date
2010-05-19
Date received
2009-11-09
Regulation
876.4370
Classification name
System, Evacuator, Fluid
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EUGENE YEUNG
Address
Dong Xing Industrial Area Kang Le Lu, Shan Xia District Heng Li, Dongguan, Guangdong CN 523466 523466

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FHF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003443SUCTION IRRIGATORApplied Medical2001-02-01
K771986CATHETER, MEDIASTINAL&PERICARDIALThe Minnesota Back Brace Co.1977-10-28

Legacy Summary#

summary

FDA Review#

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