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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 K102791
Device Name EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
Applicant
Image Stream Medical, Inc.
One Monarch Dr.
Littleton,  MA  01460
Applicant Contact BETH CYR
Correspondent
Image Stream Medical, Inc.
One Monarch Dr.
Littleton,  MA  01460
Correspondent Contact BETH CYR
Regulation Number878.4580
Classification Product Code
FTA  
Date Received09/27/2010
Decision Date 11/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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