Porex Quality Plastic Surgery Instruments
FDA 510(k) K872947 · Porex Medical
510(k) numberK872947
Submission
- Device name
- Porex Quality Plastic Surgery Instruments
- Applicant
- Porex Medical
Fairburn, GA, US - Received
- July 28, 1987
- Decision date
- August 21, 1987
- 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 |
| K872092 | Osteotome Set, Hoke, Straight, Set of 5KDG · Traditional | Military Engineering, Inc. | 06/23/1987SE |
| K842824 | Chermel Bone ChiselsKDG · Traditional | Cher Mel Corp. | 08/02/1984SE |
| 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 |
|---|---|---|
| K872791 | Porex Nerve LocatorETN · Traditional | 10/20/1987SE |
| K873044 | Porex Otology InstrumentsLRC · Traditional | 09/04/1987SE |
| K863946 | Porex(Tm) Extra-Ocular Orbital ImplantHQX · Traditional | 02/27/1987SE |
| K863943 | Porex(Tm) Eye Sphere ImplantHPZ · Traditional | 02/27/1987SE |
| K870257 | Porex(Tm) Silicone Surgical Implants for E.N.T. · Traditional | 02/24/1987SE |
| K870182 | Porex(Tm) Malar Implant · Traditional | 02/24/1987SE |
| K870154 | Porex(Tm) Tissue ExpanderLCJ · Traditional | 02/24/1987SE |
| K863942 | Porex(Tm) Nose ProsthesisFZE · Traditional | 10/24/1986SE |
| K863941 | Porex(Tm) Prosthesis, Chin, InternalFWP · Traditional | 10/24/1986SE |
| K863939 | Porex(Tm) Ear ProsthesisFZD · Traditional | 10/24/1986SE |
Questions and answers
When was Porex Quality Plastic Surgery Instruments cleared by the FDA?
Porex Quality Plastic Surgery Instruments (K872947) received a 510(k) decision of Substantially Equivalent on August 21, 1987, 24 days after the submission was received.
What is the product code of K872947?
The FDA product code is KDG – Chisel (Osteotome), a Class I (low risk) device regulated under 21 CFR 878.4820.