510(k) K051999
K051999 is an FDA 510(k) premarket notification submitted by Bisco, Inc. for the device "BISCOVER LED". The FDA issued a decision of Substantially Equivalent on August 22, 2005. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Bisco, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2005
- Date Received
- July 25, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type