Creat Brand Malar Implant
FDA 510(k) K873434 · Aesthetech Corp.
510(k) numberK873434
Submission
- Device name
- Creat Brand Malar Implant
- Applicant
- Aesthetech Corp.
Paso Robles, CA, US - Received
- August 26, 1987
- Decision date
- September 11, 1987
- 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 |
|---|---|---|
| K873940 | Creat Brand O-Rise General AspiratorBTA · Traditional | 11/25/1987SE |
| K853189 | Creat Brand I/A Pack Creat Brand Phaco PackHQC · Traditional | 09/24/1985SE |
| K843678 | Creat Brand Skin ExpanderLCJ · Traditional | 11/06/1984SE |
| K841283 | Disposable Suction Tubing Set · Traditional | 04/24/1984SE |
| K812210 | Creat Brand Wagner Chin ImplantFWP · Traditional | 09/11/1981SE |
Questions and answers
When was Creat Brand Malar Implant cleared by the FDA?
Creat Brand Malar Implant (K873434) received a 510(k) decision of Substantially Equivalent on September 11, 1987, 16 days after the submission was received.
What is the product code of K873434?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.