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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K070157
Device Name OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
Original Applicant
OMNIGUIDE, INC.
one kendall square, bldg 100
3rd floor
cambridge,  MA  02139
Original Contact douglas w woodruff
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/17/2007
Decision Date 02/01/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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