FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COBBLER'S CHIP SPLINTS
K Number: K810110
·
Decision Jan 26, 1981
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
30
Applicant Total
18
Review Days
10
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Basic Information
- Device Name
- COBBLER'S CHIP SPLINTS
- K Number
- K810110
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5940
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Secol Co.
- Date Received
- January 16, 1981
- Decision Date
- January 26, 1981
- 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
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FDA Class 1
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CLINITEX CAST PADDING
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FDA Class 1
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CLINITEX STOCKINETTE
FDA 510(k)
FDA Class 1
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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 Secol Co.
| K Number | Device Name | ||
|---|---|---|---|
| K802790 | SOLVALINE | Feb 13, 1981 | Substantially Equivalent |
| K810111 | CELLONA PLASTER VARNISH | Feb 4, 1981 | Substantially Equivalent |
| K810109 | METAL 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 |