CHERMEL BONE CHISELS
FDA 510(k) clearance K842824 · decided 1984-08-02
Clearance details
- K-number
- K842824
- Device name
- CHERMEL BONE CHISELS
- Applicant
- Cher Mel Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-19
- Decision date
- 1984-08-02
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KDG
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (K952678) | Avail-Southwest Division | 1995-07-10 |
| OMNI-JUG (K952200) | Waterstone Medical, Inc. | 1995-06-29 |
| SURGICAL CHISEL/OSTEOTOME (K894785) | Fdt Precision Machine Co., Inc. | 1989-08-18 |
| SIL-MED WASTE FLUID DUMP BAG (K891471) | Sil-Med Corp. | 1989-08-15 |
| POREX QUALITY PLASTIC SURGERY INSTRUMENTS (K872947) | Porex Medical | 1987-08-21 |
| OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (K872092) | Military Engineering, Inc. | 1987-06-23 |
| ANDERSON-NEIVERT OSTEOTOME (K772373) | Edward Weck, Inc. | 1978-03-09 |
| NEIVERT OSTEOTOME (K772376) | Edward Weck, Inc. | 1978-03-09 |
| SILVER OSTEOTOME (K772374) | Edward Weck, Inc. | 1978-03-09 |
| CEMENT EXTRACTION INSTRUMENT SET (K780135) | Orthopedic Equipment Co., Inc. | 1978-01-31 |
Recalls involving this device
No recalls on record reference this clearance.