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510(k) K861164

Device
OSTEOMILL BONE GRINDER
Applicant
BIODYNAMIC TECHNOLOGIES, INC.
510(k) number
K861164
Product code
LYS  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-02
Date received
1986-03-28
Regulation
888.4540
Classification name
Bone Mill
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KEVIN J DUNLEAVY
Address
727 Twenty-Third St. S. Arlington VA US 22202 22202

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LYS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K883183TRACER BONE MILLDe Medica Mfg., Inc.1988-10-12
K860356ORTHOBLEND POWERED BONE MILLZimmer, Inc.1986-07-08
K860016AESCULAP BONE MILLAesculap Instruments Corp.1986-03-19

Legacy Summary#

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FDA Review#

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