510(k) K864775
K864775 is an FDA 510(k) premarket notification submitted by New England Surgical Instrument Corp. for the device "CHISEL (OSTEOTOME, GOUGE, ETC.)". The FDA issued a decision of Substantially Equivalent on February 12, 1987. The device falls under product code EMM (Chisel, Osteotome, Surgical), a Class I device regulated under 21 CFR 872.4565. New England Surgical Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1987
- Date Received
- December 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chisel, Osteotome, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type