510(k) K130553
K130553 is an FDA 510(k) premarket notification submitted by Pharmaplast S.A.E. for the device "ABSOCLEAR". The FDA issued a decision of Substantially Equivalent on Jul 3, 2013. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 3, 2013
- Date Received
- Mar 4, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)