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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 K010716
Device Name VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB
Applicant
Valmed Corp.
555 Thirteenth St., NW
Columbia Sq.
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Valmed Corp.
555 Thirteenth St., NW
Columbia Sq.
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received03/09/2001
Decision Date 05/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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