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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, Ceiling Mounted
510(k) Number K040735
Device Name ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
Applicant
ALM S.A.
1777 EAST HENRIETTA ROAD
ROCHESTER,  NY  14623 -3133
Applicant Contact FREDERICK R CATT
Correspondent
ALM S.A.
1777 EAST HENRIETTA ROAD
ROCHESTER,  NY  14623 -3133
Correspondent Contact FREDERICK R CATT
Regulation Number878.4580
Classification Product Code
FSY  
Date Received03/22/2004
Decision Date 05/21/2004
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
Recalls CDRH Recalls
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