510(k) K801042
K801042 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE". The FDA issued a decision of Substantially Equivalent on June 26, 1980. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 1980
- Date Received
- May 2, 1980
- 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