510(k) K992447

50 W METAL HALIDE ILLUMINATOR, VES 0501. by Angiolaz, Inc. — Product Code FCW

K992447 is an FDA 510(k) premarket notification submitted by Angiolaz, Inc. for the device "50 W METAL HALIDE ILLUMINATOR, VES 0501.". The FDA issued a decision of Substantially Equivalent on October 20, 1999. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500. Angiolaz, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1999
Date Received
July 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type