510(k) K854711
K854711 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "FIBRELIGHT ILLUMINATING ORAL RETRACTORS". The FDA issued a decision of Substantially Equivalent on February 25, 1986. The device falls under product code EIG (Retractor, All Types), a Class I device regulated under 21 CFR 872.4565. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1986
- Date Received
- November 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor, All Types
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type