510(k) K090597
K090597 is an FDA 510(k) premarket notification submitted by Pascal Co., Inc. for the device "FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH". The FDA issued a decision of Substantially Equivalent on Mar 16, 2009. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Pascal Co., Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 2009
- Date Received
- Mar 5, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type
- 510(k)