510(k) K130580
K130580 is an FDA 510(k) premarket notification submitted by Dmg USA, Inc. for the device "RETRACTION PASTE". The FDA issued a decision of Substantially Equivalent on February 25, 2014. The device falls under product code MVL (Cord, Retraction), a Class U device. Dmg USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2014
- Date Received
- March 5, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cord, Retraction
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type