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510(k) K874358

Device
COMBINATION WRENCHES
Applicant
MED-TOOL, INC.
510(k) number
K874358
Product code
HXC  
Decision
Substantially Equivalent (SESE)
Decision date
1987-11-23
Date received
1987-10-23
Regulation
888.4540
Classification name
Wrench
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN 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 HXC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K180092IntellitorqGauthier Biomedical, Inc.2018-03-08
K874359ADJUSTABLE WRENCHESMed-Tool, Inc.1987-11-23
K870053TORQUEDRIVER WRENCHJerome Medical1987-03-11
K813067SPINAL WRENCHTwin City Surgical, Inc.1981-11-24
K791073WRENCHTruth, Inc.1979-06-20

Legacy Summary#

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FDA Review#

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