FDA 510(k) Application Details - K984124

Device Classification Name	Light, Surgical, Floor Standing   More FDA Info for this Device
510(K) Number	K984124
Device Name	Light, Surgical, Floor Standing
Applicant	AESCULAP, INC. 1000 GATEWAY BLVD. SOUTH SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	MARY ELLEN HOLDEN Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FSS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1998
Decision Date	02/01/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review