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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Accessories
510(k) Number K081698
Device Name MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
Applicant
IMAGE STREAM MEDICAL, INC.
11 MYSTIC AVE.
WINCHESTER,  MA  01890 -2920
Applicant Contact CHAS BURR
Correspondent
IMAGE STREAM MEDICAL, INC.
11 MYSTIC AVE.
WINCHESTER,  MA  01890 -2920
Correspondent Contact CHAS BURR
Regulation Number878.4580
Classification Product Code
FTA  
Date Received06/17/2008
Decision Date 07/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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