510(k) K100234

HM-LAMP II by Hillusa, Inc. — Product Code FTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2010
Date Received
January 26, 2010
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