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510(k) K844145

Device
GENERAL SURGICAL FILES
Applicant
MED-TOOL, INC.
510(k) number
K844145
Product code
GEO  
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-20
Date received
1984-10-23
Regulation
878.4800
Classification name
File, Surgical, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN M MAYERIK
Address
12434 Matthews Ln. St. Louis MO US 63127 63127

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GEO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K830675ORAL SPONGEUnisplint Corp.1983-03-24

Legacy Summary#

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FDA Review#

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