510(k) K864689
K864689 is an FDA 510(k) premarket notification submitted by Alba Health Care for the device "ALBA HEALTH CARE IODOFORM PACKING STRIP". The FDA issued a decision of Substantially Equivalent on January 20, 1987. Alba Health Care has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 1987
- Date Received
- December 2, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No