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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 -1304
Applicant Contact LEIGH WEINTRAUB
Correspondent
ENDOMEDIX
2162 MICHELSON DR.
IRVINE,  CA  92715 -1304
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
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