510(k) K843704
K843704 is an FDA 510(k) premarket notification submitted by Mcghan Medical Corp. for the device "MCGHAN TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on October 31, 1984. 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
- October 31, 1984
- Date Received
- September 21, 1984
- 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