510(k) K990332
K990332 is an FDA 510(k) premarket notification submitted by Dumex Medical Surgical Products, Ltd. for the device "DUMEX IODOFORM PACKING STRIP". The FDA issued a decision of SN on April 14, 1999. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Dumex Medical Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- April 14, 1999
- Date Received
- February 3, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type