510(k) K821258
K821258 is an FDA 510(k) premarket notification submitted by Selomas, Inc. for the device "SELOPOR". The FDA issued a decision of Substantially Equivalent on August 19, 1982. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Selomas, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1982
- Date Received
- April 30, 1982
- 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