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510(k) K925395

Device
TECHNOMED PULSOLITH 4000 LASER SYSTEM
Applicant
TEKNOMED, INC.
510(k) number
K925395
Product code
LNX  
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-21
Date received
1992-10-26
Regulation
510(k) Premarket Notification
Classification name
Medical Computers And Software
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEAN-LUC BOULNOIS
Address
North Woods Business Park 99 Rosewood Dr., Suite 140 Danvers MA US 01923 01923

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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