Seare Biomedical Silicone Block
FDA 510(k) K983043 · Seare Biomedical Corp.
510(k) numberK983043
Submission
- Device name
- Seare Biomedical Silicone Block
- Applicant
- Seare Biomedical Corp.
Salt Lake City, UT, US - Received
- August 31, 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
- MIC – Implant, Muscle, Pectoralis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code MIC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021337 | Aart Pectoralis ImplantMIC · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/03/2002SE |
| K002633 | Silmax Pectoral ImplantMIC · Traditional | Pillar Surgical, Inc. | 11/21/2000SE |
| K982762 | Seare Biomedical Pectoralis ImplantMIC · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
| K973729 | Powerflex Pec ImplantMIC · Traditional | Hanson Medical, Inc. | 12/24/1997SE |
| K961072 | Pec ImplantMIC · Traditional | Rand Scientific Corp. | 04/19/1996SE |
| K944163 | Spectrum Disigns Pectoral ImplantMIC · Traditional | Spectrum Designs, Inc. | 11/07/1994SE |
| K913768 | Pec ImplantMIC · Traditional | Applied Biomaterial Technologies | 02/03/1992SE |
More from Applied Biomaterial Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K983792 | Seare Biomedical Silicone Tissue ExpanderLCJ · Traditional | 12/11/1998SE |
| K983630 | Seare Biomedical Silicone RodsMIB · Traditional | 12/11/1998SE |
| K983041 | Seare Biomedical Silicone SheetingMIB · Traditional | 09/30/1998SE |
| K982763 | Seare Biomedical Malar ImplantsLZK · 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 Silicone Block cleared by the FDA?
Seare Biomedical Silicone Block (K983043) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 30 days after the submission was received.
What is the product code of K983043?
The FDA product code is MIC – Implant, Muscle, Pectoralis, a Class II (moderate risk) device regulated under 21 CFR 874.3620.