Chermel Bone Chisels
FDA 510(k) K842824 · Cher Mel Corp.
510(k) numberK842824
Submission
- Device name
- Chermel Bone Chisels
- Applicant
- Cher Mel Corp.
Mchenry, IL, US - Received
- July 19, 1984
- Decision date
- August 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDG – Chisel (Osteotome)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952678 | Sta-Clear Alcohol-Free Endoscopic Anti-Fog KitKDG · Traditional | Avail-Southwest Division | 07/10/1995SE |
| K952200 | Omni-JugKDG · Traditional | Waterstone Medical, Inc. | 06/29/1995SE |
| K894785 | Surgical Chisel/OsteotomeKDG · Traditional | Fdt Precision Machine Co., Inc. | 08/18/1989SE |
| K891471 | Sil-Med Waste Fluid Dump BagKDG · Traditional | Sil-Med Corp. | 08/15/1989SE |
| K872947 | Porex Quality Plastic Surgery InstrumentsKDG · Traditional | Porex Medical | 08/21/1987SE |
| K872092 | Osteotome Set, Hoke, Straight, Set of 5KDG · Traditional | Military Engineering, Inc. | 06/23/1987SE |
| K772376 | Neivert OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K772374 | Silver OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K772373 | Anderson-Neivert OsteotomeKDG · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K780135 | Cement Extraction Instrument SetKDG · Traditional | Orthopedic Equipment Co., Inc. | 01/31/1978SE |
More from Orthopedic Equipment Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863040 | Disposable Intravenous Hyperalimentation BagsKPE · Traditional | 10/31/1986SE |
| K851516 | Chermel Scalp Vein SetFPA · Traditional | 08/23/1985SE |
| K843324 | Sprague RAPPAPORT/SH-6008 Dispos. StethLDE · Traditional | 06/06/1985SE |
| K842203 | Littman Type SH-6010, Nurse TypeLDE · Traditional | 06/06/1985SE |
| K842823 | Chermel OsteotomesGFI · Traditional | 08/02/1984SE |
| K842822 | Chermel Bone GougesGDH · Traditional | 08/02/1984SE |
Questions and answers
When was Chermel Bone Chisels cleared by the FDA?
Chermel Bone Chisels (K842824) received a 510(k) decision of Substantially Equivalent on August 2, 1984, 14 days after the submission was received.
What is the product code of K842824?
The FDA product code is KDG – Chisel (Osteotome), a Class I (low risk) device regulated under 21 CFR 878.4820.