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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 K062423
Device Name OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM
Applicant
OMNIGUIDE, INC.
ONE KENDALL SQUARE, BLDG 100
3RD FLOOR
CAMBRIDGE,  MA  02139
Applicant Contact DOUGLAS W WOODRUFF
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/18/2006
Decision Date 09/21/2006
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
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