The following data is part of a premarket notification filed by Seare Biomedical Corp. with the FDA for Seare Biomedical Silicone Tissue Expander.
| Device ID | K983792 |
| 510k Number | K983792 |
| Device Name: | SEARE BIOMEDICAL SILICONE TISSUE EXPANDER |
| Classification | Expander, Skin, Inflatable |
| Applicant | SEARE BIOMEDICAL CORP. 3190 CHULA VISTA CIRCLE Salt Lake City, UT 84121 |
| Contact | William John Seare Jr |
| Correspondent | William John Seare Jr SEARE BIOMEDICAL CORP. 3190 CHULA VISTA CIRCLE Salt Lake City, UT 84121 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-27 |
| Decision Date | 1998-12-11 |
| Summary: | summary |