510(k) K110062
K110062 is an FDA 510(k) premarket notification submitted by Medipurpose Pte. , Ltd. for the device "MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG". The FDA issued a decision of Substantially Equivalent on Sep 1, 2011. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Medipurpose Pte. , Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 1, 2011
- Date Received
- Jan 10, 2011
- 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)