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510(k) K850483

Device
MICRO-AIRE STERNUM SAW REPLACEMENT BLADES
Applicant
MICRO-AIRE SURGICAL INSTRUMENTS, INC.
510(k) number
K850483
Product code
DWH  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-01
Date received
1985-02-07
Regulation
878.4820
Classification name
Blade, Saw, Surgical, Cardiovascular
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GERALD BROOKS
Address
505 Fourth St. San Fernando CA US 91340 91340

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DWH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904352CODMAN COLLINS RADIOPARENT STERNAL BLADESCodman & Shurtleff, Inc.1990-11-21
K862474HALL STERNUM SAWHall Surgical, Division of Zimmer, Inc.1986-07-17
K830189CARDIOVASCULAR SAW BLADESTemp Medical Products, Inc.1983-03-24

Legacy Summary#

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FDA Review#

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