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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, Endoscopic
510(k) Number K943342
Device Name MEDICAM XENON LIGHT SOURCE
Applicant
M.P. Video, Inc.
4 Marc Rd.
Medway,  MA  02053
Applicant Contact WINIFRED SHANNON
Correspondent
M.P. Video, Inc.
4 Marc Rd.
Medway,  MA  02053
Correspondent Contact WINIFRED SHANNON
Regulation Number878.4580
Classification Product Code
FSW  
Date Received07/12/1994
Decision Date 10/17/1994
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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