510(k) K770305
K770305 is an FDA 510(k) premarket notification submitted by Dentronix, Inc. for the device "CUTTER, P607 BONE". The FDA issued a decision of Substantially Equivalent on Mar 9, 1977. The device falls under product code FZT (Cutter, Surgical), a Class I device regulated under 21 CFR 878.4800. Dentronix, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 9, 1977
- Date Received
- Feb 16, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cutter, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt