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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Fiberoptic, Surgical Field
510(k) Number K922837
Device Name S1500 XENON LIGHT SOURCE
Applicant
Endomedix
2162 Michelson Dr.
Irvine,  CA  92715
Applicant Contact LEIGH WEINTRAUB
Correspondent
Endomedix
2162 Michelson Dr.
Irvine,  CA  92715
Correspondent Contact LEIGH WEINTRAUB
Regulation Number878.4580
Classification Product Code
HBI  
Date Received06/12/1992
Decision Date 11/03/1992
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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