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510(k) K850906

Device
TACTILE PLUS DENTAL ELEVATORS
Applicant
IPCO CORP.
510(k) number
K850906
Product code
EMJ  
Decision
Substantially Equivalent (SESE)
Decision date
1985-04-12
Date received
1985-03-05
Regulation
872.4565
Classification name
Elevator, Surgical, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEONARD L WOLFSON
Address
1025 Westchester Ave. White Plains NY US 10604 10604

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EMJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870589ELEVATOR, ROOT, SINGLE-ENDEDMilitary Engineering, Inc.1987-04-03
K851717880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATORArtiberia1985-06-14
K851713680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVAArtiberia1985-06-11
K821788BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHTPacific Dental Corp.1982-07-06
K771747PERIOSTEAL ELEVATORDepuy, Inc.1977-09-28

Legacy Summary#

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FDA Review#

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