510(k) K012320

Device
POWERPRO BATTERY SYSTEM
Applicant
LINVATEC CORP.
510(k) number
K012320
Product code
HAB  
Decision
Substantially Equivalent (SESE)
Decision date
2001-10-19
Date received
2001-07-23
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
LAURA D SENEFF
Address
11311 Concept Blvd. Largo FL US 33773 33773

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
K935517SNAP STERNUM SAWSurgiquip, Inc.1994-03-10

Legacy Summary#

summary

FDA Review#

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