510(k) K082157
K082157 is an FDA 510(k) premarket notification submitted by Kettenbach GmbH & Co. KG for the device "KETTOSIL AND SILGINAT". The FDA issued a decision of Substantially Equivalent on August 6, 2008. 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
- August 6, 2008
- Date Received
- July 31, 2008
- 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