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510(k) K841628

Device
WIRE
Applicant
PLASTAFIL, INC.
510(k) number
K841628
Product code
HXN  
Decision
Substantially Equivalent (SESE)
Decision date
1984-07-23
Date received
1984-04-19
Regulation
888.4540
Classification name
Applier, Cerclage
Medical specialty
Orthopedic
Review panel
Orthopedic
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 HXN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K024022OSTEO-CABLE SLEEVEBiomet, Inc.2003-01-23

Legacy Summary#

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FDA Review#

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