510(k) K092867
K092867 is an FDA 510(k) premarket notification submitted by Kettenbach GmbH & Co. KG for the device "IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT". The FDA issued a decision of Substantially Equivalent on October 1, 2009. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Kettenbach GmbH & Co. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2009
- Date Received
- September 18, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type