510(k) K895715

HANAULUX(R) 2000 by W.C. Heraeus GmbH — Product Code FTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1989
Date Received
September 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type