FDA.reportPublic FDA data

510(k) K851881

Device
Orthopeadic Cement Delivery System
Applicant
DENTSPLY INTL.
510(k) number
K851881
Product code
KIH
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-13
Date received
1985-04-29
Regulation
888.4200
Classification name
Dispenser, Cement
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN O SEMMELMAN
Address
570 W. College Ave. P.O. Box 872 York PA US 17405 17405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KIH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042591SMARTMIX PRE-FILLED MIXING SYSTEMDePuy Orthopaedics, Inc.2004-10-22
K943906P.F.C. CEMENT PRESSURIZING SYSTEMJohnson & Johnson Professionals, Inc.1994-12-21
K897134CMW CEMENT PRESSURISATION SYSTEMDentsply Intl.1990-03-02
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