510(k) K150898
K150898 is an FDA 510(k) premarket notification submitted by Moller Medical GmbH for the device "LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm". The FDA issued a decision of Substantially Equivalent on Dec 18, 2015. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Moller Medical GmbH has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 18, 2015
- Date Received
- Apr 2, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shunt, Central Nervous System And Components
- Device Class
- Class II
- Regulation Number
- 882.5550
- Review Panel
- NE
- Submission Type
- 510(k)