510(k) K982762
- Device
- SEARE BIOMEDICAL PECTORALIS IMPLANT
- Applicant
- SEARE BIOMEDICAL CORP.
- 510(k) number
- K982762
- Product code
- MIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-09-30
- Date received
- 1998-08-06
- Regulation
- 874.3620
- Classification name
- Implant, Muscle, Pectoralis
- Medical specialty
- Ear Nose & Throat
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM JOHN SEARE, JR.
- Address
- 3190 Chula Vista Cir. Salt Lake City UT US 84121 84121
FDA Registration Numbers#
- 2028924
- 3003897287
- 2029275
- 2031444
Source Documents#
Other 510(k) Records For Product Code MIC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021337 | AART PECTORALIS IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-03 |
| K002633 | SILMAX PECTORAL IMPLANT | Pillar Surgical, Inc. | 2000-11-21 |
| K983043 | SEARE BIOMEDICAL SILICONE BLOCK | Seare Biomedical Corp. | 1998-09-30 |
| K973729 | POWERFLEX PEC IMPLANT | Hanson Medical, Inc. | 1997-12-24 |
| K961072 | PEC IMPLANT | Rand Scientific Corp. | 1996-04-19 |
| K944163 | SPECTRUM DISIGNS PECTORAL IMPLANT | Spectrum Designs, Inc. | 1994-11-07 |
| K913768 | PEC IMPLANT | Applied Biomaterial Technologies | 1992-02-03 |
Legacy Summary#
summary
FDA Review#
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