FDA.reportPublic FDA data

510(k) K883183

Device
Tracer Bone Mill
Applicant
DE MEDICA MFG., INC.
510(k) number
K883183
Product code
LYS
Decision
Substantially Equivalent (SESE)
Decision date
1988-10-12
Date received
1988-07-28
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
VINCE DECOSTE
Address
333 S. 11th St. Santa Paula CA US 93060 93060

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
K860356ORTHOBLEND POWERED BONE MILLZimmer, Inc.1986-07-08
K861164OSTEOMILL BONE GRINDERBiodynamic Technologies, Inc.1986-05-02
K860016AESCULAP BONE MILLAesculap Instruments Corp.1986-03-19