510(k) K961893
K961893 is an FDA 510(k) premarket notification submitted by Pharmascience, Inc. for the device "DURAFLOR". The FDA issued a decision of Substantially Equivalent on Aug 14, 1996. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Pharmascience, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 14, 1996
- Date Received
- May 16, 1996
- Clearance Type
- Traditional
- 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)