510(k) K945370
K945370 is an FDA 510(k) premarket notification submitted by Bisco, Inc. for the device "C-POST". The FDA issued a decision of Substantially Equivalent on March 31, 1995. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Bisco, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1995
- Date Received
- November 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Post, Root Canal
- Device Class
- Class I
- Regulation Number
- 872.3810
- Review Panel
- DE
- Submission Type