Seare Biomedical Malar Implants
FDA 510(k) K982763 · Seare Biomedical Corp.
510(k) numberK982763
Submission
- Device name
- Seare Biomedical Malar Implants
- Applicant
- Seare Biomedical Corp.
Salt Lake City, UT, US - Received
- August 6, 1998
- Decision date
- September 30, 1998
- 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 |
| 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 |
| K973574 | Duralastic Anatomical Malar ImplantLZK · Traditional | Hanson Medical, Inc. | 10/24/1997SE |
More from Hanson Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983792 | Seare Biomedical Silicone Tissue ExpanderLCJ · Traditional | 12/11/1998SE |
| K983630 | Seare Biomedical Silicone RodsMIB · Traditional | 12/11/1998SE |
| K983043 | Seare Biomedical Silicone BlockMIC · Traditional | 09/30/1998SE |
| K983041 | Seare Biomedical Silicone SheetingMIB · Traditional | 09/30/1998SE |
| K982762 | Seare Biomedical Pectoralis ImplantMIC · Traditional | 09/30/1998SE |
| K982753 | Seare Biomedical Nasal ImplantsFZE · Traditional | 09/30/1998SE |
| K982752 | Seare Biomedical Chin ImplantsFWP · Traditional | 09/30/1998SE |
Questions and answers
When was Seare Biomedical Malar Implants cleared by the FDA?
Seare Biomedical Malar Implants (K982763) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 55 days after the submission was received.
What is the product code of K982763?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.