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510(k) K780255

Device
NEEDLE DRIVER
Applicant
SCANLAN INTL., INC.
510(k) number
K780255
Product code
GFC  
Decision
Substantially Equivalent (SESE)
Decision date
1978-04-18
Date received
1978-02-16
Regulation
878.4820
Classification name
Driver, Surgical, Pin
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GFC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K781450DRIVERSOrthopedic Equipment Co., Inc.1978-09-27

Legacy Summary#

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FDA Review#

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