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510(k) K973865

Device
BIRTCHER UV LAMP
Applicant
MEDFAXX, INC.
510(k) number
K973865
Product code
MXG  
Decision
Substantially Equivalent (SESE)
Decision date
1999-02-26
Date received
1997-10-06
Regulation
878.4630
Classification name
Lamp, Uvc, (for Treating Skin And Wounds)
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BOB JOHNSON
Address
P.O. Box 17827 Raleigh NC US 27619 27619

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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