510(k) K113839
K113839 is an FDA 510(k) premarket notification submitted by Parkell, Inc. for the device "RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE". The FDA issued a decision of Substantially Equivalent on April 12, 2012. The device falls under product code MVL (Cord, Retraction), a Class U device. Parkell, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2012
- Date Received
- December 28, 2011
- 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