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510(k) K901166

Device
DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER
Applicant
DALTON TECHNOLOGY, INC.
510(k) number
K901166
Product code
HXX  
Decision
Substantially Equivalent (SESE)
Decision date
1990-06-13
Date received
1990-03-13
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
JAMES LAFFERTY
Address
6062 San Fernando Rd. Glendale CA US 91202 91202

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
K873066ACROMED SCREW DRIVERBuckman Co., Inc.1987-09-02
K872389PRECISION SCREW DRIVER SETMed-Tool, Inc.1987-07-15
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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