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510(k) K862523

Device
MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS
Applicant
WALTER LORENZ SURGICAL, INC.
510(k) number
K862523
Product code
EKW  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-01
Date received
1986-07-02
Regulation
872.4565
Classification name
Broach, Endodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DEBRA A POWERS
Address
1520 Tradeport Dr. Jacksonville FL US 32218 32218

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EKW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871493DENTI-TRAY(TM)Advanced Medical, Inc.1987-06-24
K870765CANNULATED INSTRUMENT CLEANERSTreace Medical, Inc.1987-05-27
K831749ENDODONTIC BROACH(76EKN) BARBED BROACHUnion Branch1983-07-12
K823489ENDODONTIC BROACH-BARBED BROACHUnion Broach, Div. Moyco Industries, Inc.1982-12-15
K800292ENDEX BROACH, ENDODONTICIpco Corp.1980-02-19
K760985HAND INSTRUMENTSAdp Intl., Inc.1976-11-15

Legacy Summary#

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FDA Review#

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