FDA.reportPublic FDA data

510(k) K010149

Device
WUJIN #3 FEMORAL NAIL
Applicant
Biopro, Inc.
510(k) number
K010149
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-17
Date received
2001-01-17
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
ANGENA PAREKH
Address
17 Seventeenth St. Port Huron MI US 48060 48060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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