FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE ORTHOPEDIC STOCKINETTE
K Number: K812904
·
Decision Jan 18, 1982
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
30
Applicant Total
8
Review Days
91
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STERILE ORTHOPEDIC STOCKINETTE
- K Number
- K812904
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5940
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Alba Health Care
- Date Received
- October 19, 1981
- Decision Date
- January 18, 1982
- Product Code
- LGF
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LGF | Component, Cast | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGF), ordered by most recent decision date.
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
FDA 510(k)
FDA Class 1
·Orthopedic
CLINITEX CAST PADDING
FDA 510(k)
FDA Class 1
·Orthopedic
CLINITEX STOCKINETTE
FDA 510(k)
FDA Class 1
·Orthopedic
PROTEC COTTON PADDING BANDAGE
FDA 510(k)
FDA Class 1
·Orthopedic
QUICK-CAST IMMOBILIZER
FDA 510(k)
FDA Class 1
·Orthopedic
CARAPACE STERILE CAST PADDING
FDA 510(k)
FDA Class 1
·Orthopedic
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 |
| K850881 | ALBA DRY BURN PAD | Apr 17, 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 |
| K803171 | PROCEDURE & RECOVERY PATIENT SUIT | Mar 4, 1981 | Substantially Equivalent |