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510(k) K872490

Device
1.1 SCREWDRIVERS
Applicant
MICRO-AIRE SURGICAL INSTRUMENTS, INC.
510(k) number
K872490
Product code
LRZ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-07-23
Date received
1987-06-23
Regulation
878.4800
Classification name
Screwdriver, Surgical
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 LRZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K896589MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERPOptik1989-12-27
K872387STANDARD SCREW DRIVERMed-Tool, Inc.1987-07-16

Legacy Summary#

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FDA Review#

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