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510(k) K935517

Device
SNAP STERNUM SAW
Applicant
SURGIQUIP, INC.
510(k) number
K935517
Product code
HAB  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-10
Date received
1993-11-18
Regulation
878.4820
Classification name
Saw, Powered, And Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARY BIGGERS
Address
Regulatory Consultants 18665 Midway Rd., Number 521 Dallas TX US 75287 75287

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HAB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K012320POWERPRO BATTERY SYSTEMLinvatec Corp.2001-10-19

Legacy Summary#

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FDA Review#

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