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510(k) K862529

Device
HALL STERILE BUR
Applicant
HALL SURGICAL, DIVISION OF ZIMMER, INC.
510(k) number
K862529
Product code
HTT  
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-15
Date received
1986-07-02
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#

Contact
DAVID D WELLINGTON
Address
P.O. Box 899 `Anta Barbara CA US 93102 93102

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
K821695MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMERMicro-Aire Surgical Instruments, Inc.1982-07-20
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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