CHISEL (OSTEOTOME, GOUGE, ETC.)
FDA 510(k) clearance K864775 · decided 1987-02-12
Clearance details
- K-number
- K864775
- Device name
- CHISEL (OSTEOTOME, GOUGE, ETC.)
- Applicant
- New England Surgical Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-05
- Decision date
- 1987-02-12
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- EMM
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Rockland, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STERI-OSS SINUS AUGMENTATION KIT (K963897) | Steri-Oss, Inc. | 1996-11-06 |
| 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS (K851714) | Artiberia | 1985-06-11 |
| SURGICAL CHISEL (K760959) | American Safety Equipment Corp. | 1976-11-15 |
Recalls involving this device
No recalls on record reference this clearance.