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510(k) K843557

Device
K-APATITE 20-40 MESH K-APATITE 40-60
Applicant
KATECHO, INC.
510(k) number
K843557
Product code
ELE  
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-30
Date received
1984-09-10
Regulation
872.3645
Classification name
Implant, Subperiosteal
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LORNE SCHARNBERG
Address
2302 SW 9th. St. Des Moines IA US 50315 50315

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ELE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210228KLS Martin IPS PreprostheticKLS-Martin L.P.2022-07-08
K862926SURGICAL VITEXJeneric Ind.1986-08-29
K801208HOLLOW BASKET TITANIUM DENTAL IMPLANTColmed, Ltd.1980-05-28

Legacy Summary#

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FDA Review#

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