510(k) K053640
K053640 is an FDA 510(k) premarket notification submitted by Direx Systems Corp. for the device "INTEGRA". The FDA issued a decision of Substantially Equivalent on March 1, 2006. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Direx Systems Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2006
- Date Received
- December 30, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Extracorporeal Shock-Wave, Urological
- Device Class
- Class II
- Regulation Number
- 876.5990
- Review Panel
- GU
- Submission Type