510(k) K983792
K983792 is an FDA 510(k) premarket notification submitted by Seare Biomedical Corp. for the device "SEARE BIOMEDICAL SILICONE TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Seare Biomedical Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1998
- Date Received
- October 27, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Expander And Accessories
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type