510(k) K942521
K942521 is an FDA 510(k) premarket notification submitted by Bull Frog Mfg. Co. for the device "CONSERVA POST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 1994. The device falls under product code ELR (Post, Root Canal), a Class I device regulated under 21 CFR 872.3810. Bull Frog Mfg. Co. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1994
- Date Received
- May 26, 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