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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, Floor Standing
510(k) Number K984124
Device Name AESCULAP XENON LIGHT SOURCE
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact MARY ELLEN HOLDEN
Correspondent
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact MARY ELLEN HOLDEN
Regulation Number878.4580
Classification Product Code
FSS  
Date Received11/18/1998
Decision Date 02/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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