510(k) K862203
K862203 is an FDA 510(k) premarket notification submitted by Mcghan Medical Corp. for the device "MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on July 23, 1986. 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
- July 23, 1986
- Date Received
- June 10, 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