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510(k) K854711

Device
FIBRELIGHT ILLUMINATING ORAL RETRACTORS
Applicant
DOWNS SURGICAL LTD.
510(k) number
K854711
Product code
EIG  
Decision
Substantially Equivalent (SESE)
Decision date
1986-02-25
Date received
1985-11-22
Regulation
872.4565
Classification name
Retractor, All Types
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JARVIS CRIBB
Address
42 Industrial Way Wilmington MA US 01887 01887

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EIG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971284OPALDAMUltradent Products, Inc.1997-06-03
K832366ZOLLER BURNED LIP CONFORMERUniversal Prosthetics, Inc.1983-09-26
K821784BEACH GINGIVAL RETRACTION INSTR. TYPE BPacific Dental Corp.1982-07-06
K771973GINGITRACTDen-Mat Corp.1977-11-07
K771399LIP & CHEEK RETRACTORL.D. Caulk Co.1977-08-26
K761024RACESTYPTINE RINGSSeptodont, Inc.1976-11-19
K760657RACESTYPTINE CORDSeptodont, Inc.1976-09-27

Legacy Summary#

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FDA Review#

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