510(k) K850881
K850881 is an FDA 510(k) premarket notification submitted by Alba Health Care for the device "ALBA DRY BURN PAD". The FDA issued a decision of Substantially Equivalent on April 17, 1985. Alba Health Care has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 1985
- Date Received
- March 4, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No