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510(k) K874503

Device
MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER
Applicant
MICRO-AIRE SURGICAL INSTRUMENTS, INC.
510(k) number
K874503
Product code
HWM  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-02
Date received
1987-11-02
Regulation
878.4800
Classification name
Osteotome
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SIDDHARTH DESAI
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 HWM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870780ACROMED WALLIE-HEINIG OSTEOTOMESBuckman Co., Inc.1987-03-09
K771744OSTEOTOMES FOR CUTTING BONHDepuy, Inc.1977-09-28

Legacy Summary#

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FDA Review#

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