510(k) K062130
K062130 is an FDA 510(k) premarket notification submitted by Hager& Meisinger GmbH for the device "MEISINGER BENEX, MODEL BE001". The FDA issued a decision of Substantially Equivalent on April 16, 2007. The device falls under product code EMG (Forceps, Tooth Extractor, Surgical), a Class I device regulated under 21 CFR 872.4565. Hager& Meisinger GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2007
- Date Received
- July 26, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Tooth Extractor, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type