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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Surgical
510(k) Number K100234
Device Name HM-LAMP II
Applicant
HILLUSA, INC.
7215 N.W. 46TH ST.
MIAMI,  FL  33166
Applicant Contact MARIA GUMA
Correspondent
HILLUSA, INC.
7215 N.W. 46TH ST.
MIAMI,  FL  33166
Correspondent Contact MARIA GUMA
Regulation Number878.4580
Classification Product Code
FTD  
Date Received01/26/2010
Decision Date 07/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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