MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP


Device Classification Name

powered laser surgical instrument

510(k) Number K073313
Device Name MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP
Applicant
OMNIGUIDE, INC.
one kendall square, bldg 100
3rd floor
cambridge, 
MA 
02139

Applicant Contact douglas w woodruff
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 11/26/2007
Decision Date 01/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party Yes

Combination Product

No