Duralastic Anatomical Nasal Implants
FDA 510(k) K973573 · Hanson Medical, Inc.
510(k) numberK973573
Submission
- Device name
- Duralastic Anatomical Nasal Implants
- Applicant
- Hanson Medical, Inc.
Kingston, WA, US - Received
- September 19, 1997
- Decision date
- November 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FZE – Prosthesis, Nose, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3680
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241253 | Medicon Epiplating SystemFZE · Traditional | Cmf Medicon Surgical, Inc. | 12/12/2024SE |
| K161548 | Osseointegrated FixturesFZE · Traditional | Southern Implants (Pty), Ltd. | 12/01/2016SE |
| K090803 | Hanson Medical Facial ImplantsFZE · Traditional | Hanson Medical, Inc. | 06/30/2010SE |
| K090630 | Nobel Biocare Endosseous Implants (Maxillofacial Indication)FZE · Traditional | Nobel Biocare AB | 06/02/2009SE |
| K071018 | Monarch Nasal ImplantFZE · Traditional | Hanson Medical, Inc. | 05/25/2007SE |
| K041690 | Monarch Nasal ImplantFZE · Traditional | Hanson Medical, Inc. | 02/11/2005SE |
| K021418 | Aart Nasal ImplantFZE · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K992242 | Pillar Nasal, Dorsal Columella and Nasal Dorsum ImplantsFZE · Traditional | Pillar Surgical, Inc. | 11/22/1999SE |
| K983755 | Nasal Dorsal SeriesFZE · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982753 | Seare Biomedical Nasal ImplantsFZE · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
More from Seare Biomedical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K141822 | Sensei X Robotic Catheter SystemDXX · Special | 08/05/2014SE |
| K090803 | Hanson Medical Facial ImplantsFZE · Traditional | 06/30/2010SE |
| K071018 | Monarch Nasal ImplantFZE · Traditional | 05/25/2007SE |
| K041690 | Monarch Nasal ImplantFZE · Traditional | 02/11/2005SE |
| K040307 | Hanson Scar AdeMDA · Traditional | 08/12/2004SE |
| K030809 | Hanson Medical Gluteal ImplantMIB · Traditional | 04/21/2003SE |
| K030808 | Hanson Medical Calf ImplantMIB · Traditional | 04/21/2003SE |
| K973730 | Durasil I and Durasil IIMIB · Traditional | 12/24/1997SE |
| K973729 | Powerflex Pec ImplantMIC · Traditional | 12/24/1997SE |
| K973728 | Silicone Carving BlockMIB · Traditional | 11/13/1997SE |
Questions and answers
When was Duralastic Anatomical Nasal Implants cleared by the FDA?
Duralastic Anatomical Nasal Implants (K973573) received a 510(k) decision of Substantially Equivalent on November 13, 1997, 55 days after the submission was received.
What is the product code of K973573?
The FDA product code is FZE – Prosthesis, Nose, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3680.