FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ALBA DRY BURN PAD
K Number: K850881
·
Decision Apr 17, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
44
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Basic Information
- Device Name
- ALBA DRY BURN PAD
- K Number
- K850881
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Alba Health Care
- Date Received
- March 4, 1985
- Decision Date
- April 17, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Alba Health Care
| K Number | Device Name | ||
|---|---|---|---|
| K864689 | ALBA HEALTH CARE IODOFORM PACKING STRIP | Jan 20, 1987 | Substantially Equivalent |
| K861154 | ALBA HEALTH CARE PLAIN PACKING STRIP | Apr 15, 1986 | Substantially Equivalent |
| K851918 | INFANT PHOTOTHERAPY MASK | Jun 7, 1985 | Substantially Equivalent |
| K850904 | ALBA DRY BURN DRESSING | Apr 17, 1985 | Substantially Equivalent |
| K850241 | ALBA HEALTH CARE NON-ADHERING DRESSING | Mar 12, 1985 | Substantially Equivalent |
| K812904 | STERILE ORTHOPEDIC STOCKINETTE | Jan 18, 1982 | Substantially Equivalent |
| K803171 | PROCEDURE & RECOVERY PATIENT SUIT | Mar 4, 1981 | Substantially Equivalent |