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510(k) K821695

Device
MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER
Applicant
MICRO-AIRE SURGICAL INSTRUMENTS, INC.
510(k) number
K821695
Product code
HTT  
Decision
Substantially Equivalent (SESE)
Decision date
1982-07-20
Date received
1982-06-08
Regulation
888.4540
Classification name
Burr, Orthopedic
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 HTT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862529HALL STERILE BURHall Surgical, Division of Zimmer, Inc.1986-07-15
K802598CARBIDE CUTTING INSTRUMENT/INTRAARTICUThe Anspach Effort, Inc.1980-11-19
K760236BUR, SURGICAL CARBIDECutter Laboratories, Inc.1976-07-26

Legacy Summary#

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FDA Review#

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