510(k) K863375
K863375 is an FDA 510(k) premarket notification submitted by Combe, Inc. for the device "SEA-BOND". The FDA issued a decision of Substantially Equivalent on September 19, 1986. The device falls under product code KXX (Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer), a Class I device regulated under 21 CFR 872.3450. Combe, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1986
- Date Received
- September 3, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
- Device Class
- Class I
- Regulation Number
- 872.3450
- Review Panel
- DE
- Submission Type