510(k) K854794
K854794 is an FDA 510(k) premarket notification submitted by Mcghan Medical Corp. for the device "MCGHAN INTEGRAL VALVE TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on December 24, 1985. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Mcghan Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 24, 1985
- Date Received
- December 2, 1985
- 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