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510(k) K974442

Device
PRE-POWDERED NITRILE EXAMINATION GLOVES
Applicant
P.T. LATEXINDO TOBAPERKASA
510(k) number
K974442
Product code
LZY  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-05
Date received
1997-11-25
Regulation
888.3360
Classification name
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HENDRA RAMALI
Address
Jalan Raya Binjai Km. 11. Medan ID

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LZY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231448TANDEM Hip SystemSmith & Nephew, Inc.2023-07-19
K111145ENDO HEADMedacta International2011-08-16
K915528BHR BIPOLAR FEMORAL HEAD COMPONENTImplantology Corp.1993-06-29
K915548IONGUARD TITANIUM MODULAR HEADSBiomet, Inc.1992-03-10
K903084MODULAR CATHCART FRACTURE SYSTEMDepuy, Inc.1990-10-03
K896580UNI-POLAR HEADRichards Medical Co., Inc.1990-02-15
K892059FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SURProtek, Inc.1989-07-19

Legacy Summary#

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FDA Review#

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