510(k) K894495
K894495 is an FDA 510(k) premarket notification submitted by Surgitek for the device "SURGITEK(R) EXTERNAL FILL PORT". The FDA issued a decision of Substantially Equivalent on January 17, 1990. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Surgitek has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1990
- Date Received
- July 19, 1989
- 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