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510(k) K860016

Device
AESCULAP BONE MILL
Applicant
AESCULAP INSTRUMENTS CORP.
510(k) number
K860016
Product code
LYS  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-19
Date received
1986-01-03
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
RON ALLEN
Address
875 Stanton Rd. Burlingame CA US 94010 94010

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
K861164OSTEOMILL BONE GRINDERBiodynamic Technologies, Inc.1986-05-02

Legacy Summary#

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FDA Review#

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