510(k) K865033
K865033 is an FDA 510(k) premarket notification submitted by Cox-Uphuff Intl. for the device "BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER". The FDA issued a decision of Substantially Equivalent on January 12, 1987. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Cox-Uphuff Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1987
- Date Received
- December 23, 1986
- 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