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510(k) K042591

Device
SMARTMIX PRE-FILLED MIXING SYSTEM
Applicant
DEPUY ORTHOPAEDICS, INC.
510(k) number
K042591
Product code
KIH  
Decision
Substantially Equivalent (SESE)
Decision date
2004-10-22
Date received
2004-09-23
Regulation
888.4200
Classification name
Dispenser, Cement
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TIFFANI ROGERS
Address
700 Orthopaedic Dr. Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KIH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943906P.F.C. CEMENT PRESSURIZING SYSTEMJohnson & Johnson Professionals, Inc.1994-12-21
K897134CMW CEMENT PRESSURISATION SYSTEMDentsply Intl.1990-03-02
K851881ORTHOPEADIC CEMENT DELIVERY SYSTEMDentsply Intl.1985-06-13
K840046PRESSURIZING/SCAVENGING ACRYLIC CEMENTPrecision Medical Devices, Inc.1984-02-09
K833675BRIGHAM TIBIAL CEMENT PRESSURIZERHowmedica Corp.1983-12-12
K811317HOWMEDICA FEMORAL PRESSURING SEALHowmedica Corp.1981-05-29
K801388OH-HARRISJohnson & Johnson Professionals, Inc.1980-07-28
K790275GUN, EXETER CEMENTHowmedica Corp.1979-02-21
K781955GUN, CEMENTDepuy, Inc.1978-12-04
K780266BONE CEMENT APPLICATORZimmer, Inc.1978-02-28

Legacy Summary#

summary

FDA Review#

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