Cui Anatomical Silicone Malar
FDA 510(k) K903329 · Cui Corp.
510(k) numberK903329
Submission
- Device name
- Cui Anatomical Silicone Malar
- Applicant
- Cui Corp.
Santa Barbara, CA, US - Received
- July 25, 1990
- Decision date
- September 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K913140 | Silicone Gel SheetingMDA · Traditional | 09/30/1991SE |
| K904350 | Cui Dorsal Columella ProsthesisFZE · Traditional | 11/26/1990SE |
| K904349 | Cui Curvilinear Silicone ChinFWP · Traditional | 11/26/1990SE |
| K904348 | Cui Feathered Silicone MalarLZK · Traditional | 11/26/1990SE |
| K903328 | Cui Premaxillary ImplantFZE · Traditional | 09/10/1990SE |
| K903327 | Cui Articulated Silicone ChinFWP · Traditional | 09/10/1990SE |
Questions and answers
When was Cui Anatomical Silicone Malar cleared by the FDA?
Cui Anatomical Silicone Malar (K903329) received a 510(k) decision of Substantially Equivalent on September 10, 1990, 47 days after the submission was received.
What is the product code of K903329?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.