Duralastic Anatomical Malar Implants
FDA 510(k) K971479 · Allied Biomedical Corp.
510(k) numberK971479
Submission
- Device name
- Duralastic Anatomical Malar Implants
- Applicant
- Allied Biomedical Corp.
Paso Robles, CA, US - Received
- April 23, 1997
- Decision date
- July 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZK – Implant, Malar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code LZK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021419 | Aart Malar ImplantLZK · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K002886 | Implantech Composite Facial Implants (Malar, Chin, and Nasal)LZK · Traditional | Implantech Associates, Inc. | 11/24/2000SE |
| K992240 | Pillar Malar ImplantLZK · Traditional | Pillar Surgical, Inc. | 11/22/1999SE |
| K983756 | Surgiform Anatomical MalarLZK · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982763 | Seare Biomedical Malar ImplantsLZK · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
| K981835 | Silimed Malar ImplantLZK · Traditional | Silimed, LLC | 07/09/1998SE |
| K980141 | Spectrum Designs Projection Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980140 | Spectrum Designs Medial Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980139 | Spectrum Designs Profile Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K973502 | Implantech Conform Binder Submalar ImplantLZK · Traditional | Implantech Associates, Inc. | 11/07/1997SE |
More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982051 | Kelocate SheetingMDA · Traditional | 08/05/1998SE |
| K971481 | Duralastic Anatomical Nasal ImplantsFZE · Traditional | 07/18/1997SE |
| K971478 | Duralastic Anatomical Chin ImplantsFWP · Traditional | 07/18/1997SE |
| K971480 | Duralastic I and Duralastic IIMIB · Traditional | 05/28/1997SE |
| K955370 | Duralastic IIMIB · Traditional | 02/08/1996SE |
| K955368 | Duralastic IMIB · Traditional | 02/08/1996SE |
| K955433 | Duralastic Silicone TubingKGZ · Traditional | 01/26/1996SE |
| K954413 | KelocoteMDA · Traditional | 11/29/1995SE |
Questions and answers
When was Duralastic Anatomical Malar Implants cleared by the FDA?
Duralastic Anatomical Malar Implants (K971479) received a 510(k) decision of Substantially Equivalent on July 18, 1997, 86 days after the submission was received.
What is the product code of K971479?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.