510(k) K862695
K862695 is an FDA 510(k) premarket notification submitted by Teledyne, Inc. for the device "FLUOR-ETCH GEL ETCHANT". The FDA issued a decision of Substantially Equivalent on July 31, 1986. The device falls under product code EBC (Sealant, Pit And Fissure, And Conditioner), a Class II device regulated under 21 CFR 872.3765. Teledyne, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1986
- Date Received
- July 15, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sealant, Pit And Fissure, And Conditioner
- Device Class
- Class II
- Regulation Number
- 872.3765
- Review Panel
- DE
- Submission Type