510(k) K821753
K821753 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "A O FIBER OPTIC ILLUMINATION, 1185A". 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