510(k) K080549
K080549 is an FDA 510(k) premarket notification submitted by Parkell, Inc. for the device "DURAFINISH ALL-CURE, MODEL S296". The FDA issued a decision of Substantially Equivalent on May 13, 2008. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310. Parkell, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2008
- Date Received
- February 27, 2008
- 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