510(k) K833502
K833502 is an FDA 510(k) premarket notification submitted by American Heyer Schulte for the device "RADOVAN SUBCUTANEOUS TISSUE EXPANDER". The FDA issued a decision of Substantially Equivalent on February 3, 1984. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. American Heyer Schulte has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 1984
- Date Received
- October 5, 1983
- 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