FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
METAL SPLINTS
K Number: K810109
·
Decision Jan 26, 1981
Classifications
1
FEI Numbers
416
Registration Numbers
416
Same Product Code
35
Applicant Total
18
Review Days
10
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
- METAL SPLINTS
- K Number
- K810109
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Secol Co.
- Date Received
- January 16, 1981
- Decision Date
- January 26, 1981
- Product Code
- ILH
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILH | Splint, Hand, And Components | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILH), ordered by most recent decision date.
SPLINT WOOD
FDA 510(k)
FDA Class 1
·Physical Medicine
SPLINTS
FDA 510(k)
FDA Class 1
·Physical Medicine
FINGER EXTENSION SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
FINGER FLEXION SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
UNIVERSAL WRIST SPLINT & FOREARM SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
WRIST SUPPORT
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Secol Co.
| K Number | Device Name | ||
|---|---|---|---|
| K802790 | SOLVALINE | Feb 13, 1981 | Substantially Equivalent |
| K810111 | CELLONA PLASTER VARNISH | Feb 4, 1981 | Substantially Equivalent |
| K810110 | COBBLER'S CHIP SPLINTS | Jan 26, 1981 | Substantially Equivalent |
| K802794 | PRO-OPHTA STICKS | Dec 22, 1980 | Substantially Equivalent |
| K802793 | LOMATUELL OINTMENT DRESSING | Dec 18, 1980 | Substantially Equivalent |
| K802799 | EYE PADS | Dec 17, 1980 | Substantially Equivalent |
| K802797 | O.R. DRAPES | Dec 17, 1980 | Substantially Equivalent |
| K802791 | ZINC PASTE BANDAGE | Dec 17, 1980 | Substantially Equivalent |
| K802787 | METALLINE DRESSINGS | Dec 17, 1980 | Substantially Equivalent |
| K802786 | POROPLAST-EYE DRESSING | Dec 17, 1980 | Substantially Equivalent |