510(k) K153243
K153243 is an FDA 510(k) premarket notification submitted by Fehling Instruments GmbH & Co. KG for the device "Fehling-Punches". The FDA issued a decision of Substantially Equivalent on August 4, 2016. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Fehling Instruments GmbH & Co. KG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2016
- Date Received
- November 9, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Manual
- Device Class
- Class II
- Regulation Number
- 882.4840
- Review Panel
- NE
- Submission Type