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510(k) K841620

Device
FRONT RADIUS CUTTER
Applicant
PLASTAFIL, INC.
510(k) number
K841620
Product code
HTX  
Decision
Substantially Equivalent (SESE)
Decision date
1984-09-20
Date received
1984-04-19
Regulation
888.4540
Classification name
Rongeur
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 HTX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874954MANUAL RONGEURSolway, Inc.1987-12-30
K841621BACK RADIUS CUTTERPlastafil, Inc.1984-09-20
K780397ORTHOPEDIC FORCEPSOrthopedic Equipment Co., Inc.1978-03-22
K760325SURGICAL INSTRUMENTS, ORTHOPEDICDepuy, Inc.1976-08-03

Legacy Summary#

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FDA Review#

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