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510(k) K872389

Device
PRECISION SCREW DRIVER SET
Applicant
MED-TOOL, INC.
510(k) number
K872389
Product code
HXX  
Decision
Substantially Equivalent (SESE)
Decision date
1987-07-15
Date received
1987-06-19
Regulation
888.4540
Classification name
Screwdriver
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MAYERIK, JR.
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 HXX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K901166DALTON TECHNOLOGY FLEXIBLE SCREWDRIVERDalton Technology, Inc.1990-06-13
K873066ACROMED SCREW DRIVERBuckman Co., Inc.1987-09-02
K8626892.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASPW. L. Gore & Associates, Inc.1986-09-02

Legacy Summary#

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FDA Review#

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