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510(k) K934970

Device
DUET
Applicant
TRULIFE LTD.
510(k) number
K934970
Product code
GBJ  
Decision
Substantially Equivalent (SESE)
Decision date
1993-12-10
Date received
1993-10-18
Regulation
878.3750
Classification name
Prosthesis, Adhesive, External
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEAN TWOHIG
Address
3 Cookstown Industrial Estate Tallaght Dublin 24 IE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K810282OPERATING TABLE ACCESSORY CLAMPMinnesota Scientific, Inc.1981-02-26
K790946GORDON IVS INTRAVENOUS STABILIZERWhitman Medical Corp.1979-06-05
K790186PROTECTIVSTABILIZERJelco Laboratories1979-02-26

Legacy Summary#

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FDA Review#

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