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510(k) K935443

Device
ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
Applicant
OSADA ELECTRIC CO., LTD.
510(k) number
K935443
Product code
DZH  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-20
Date received
1993-11-12
Regulation
872.4120
Classification name
Saw, Bone, Ac-powered
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
YOSHINO CHARLENE HARA
Address
8242 W. 3rd St., Suite 150 Los Angeles CA US 90048 90048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DZH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K031793DENTATUS OSCIOMATDentatus USA , Ltd.2003-11-13
K760958SURGICAL OSCILLATING SAWAmerican Safety Equipment Corp.1976-11-16
K760957SURGICAL RECIPROCATING SAWAmerican Safety Equipment Corp.1976-11-15

Legacy Summary#

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FDA Review#

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