510(k) K850881

ALBA DRY BURN PAD by Alba Health Care

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