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510(k) K952006

Device
ACCU-BEAM FIBER OPTIC HANDPIECE
Applicant
TTI MEDICAL
510(k) number
K952006
Product code
GEX  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-31
Date received
1995-04-28
Regulation
878.4810
Classification name
Powered Laser Surgical Instrument
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ALLEN R HOWES
Address
7026 Koll Center Pkwy. Suite 207 Pleasanton CA US 94566 94566

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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