The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Chisel (osteotome, Gouge, Etc.).
| Device ID | K864775 |
| 510k Number | K864775 |
| Device Name: | CHISEL (OSTEOTOME, GOUGE, ETC.) |
| Classification | Chisel, Osteotome, Surgical |
| Applicant | NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Contact | Richard M Beane |
| Correspondent | Richard M Beane NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370 |
| Product Code | EMM |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-05 |
| Decision Date | 1987-02-12 |