The following data is part of a premarket notification filed by Seare Biomedical Corp. with the FDA for Seare Biomedical Silicone Block.
| Device ID | K983043 |
| 510k Number | K983043 |
| Device Name: | SEARE BIOMEDICAL SILICONE BLOCK |
| Classification | Implant, Muscle, Pectoralis |
| Applicant | SEARE BIOMEDICAL CORP. 3190 CHULA VISTA CIRCLE Salt Lake City, UT 84121 |
| Contact | William J Seare, Jr |
| Correspondent | William J Seare, Jr SEARE BIOMEDICAL CORP. 3190 CHULA VISTA CIRCLE Salt Lake City, UT 84121 |
| Product Code | MIC |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-31 |
| Decision Date | 1998-09-30 |
| Summary: | summary |