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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 K070071
Device Name OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER
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 Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/08/2007
Decision Date 01/25/2007
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
Predetermined Change
Control Plan Authorized		 No
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