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510(k) K911120

Device
DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
Applicant
HAMO USA, INC.
510(k) number
K911120
Product code
MEC  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-03
Date received
1991-03-11
Regulation
880.6992
Classification name
Disinfector, Medical Devices
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALFREDO MUNOZ
Address
10100 NW 116th Way, Suite 14 Miami FL US 33178 33178

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MEC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081094OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500Olympic Medical Corp.2008-06-20

Legacy Summary#

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FDA Review#

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