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510(k) K840735

Device
FEMORAL CEMENT REMOVAL INSTRUMENT
Applicant
AMTECH SCIENTIFIC, INC.
510(k) number
K840735
Product code
HWX  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-14
Date received
1984-02-21
Regulation
888.4540
Classification name
Tap, Bone
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 HWX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873067ACROMED BONE SCREW TAP SLEEVESBuckman Co., Inc.1987-09-02

Legacy Summary#

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FDA Review#

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