510(k) K821754

A O FIBER OPTIC ILLUMINATOR, 1185B by Warner-Lambert Co. — Product Code FCR

K821754 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "A O FIBER OPTIC ILLUMINATOR, 1185B". The FDA issued a decision of Substantially Equivalent on June 24, 1982. The device falls under product code FCR (Light Source, Photographic, Fiberoptic), a Class II device regulated under 21 CFR 876.1500. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1982
Date Received
June 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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