FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLVALINE
K Number: K802790
·
Decision Feb 13, 1981
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
18
Review Days
101
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Basic Information
- Device Name
- SOLVALINE
- K Number
- K802790
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Secol Co.
- Date Received
- November 4, 1980
- Decision Date
- February 13, 1981
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Secol Co.
| K Number | Device Name | ||
|---|---|---|---|
| K810111 | CELLONA PLASTER VARNISH | Feb 4, 1981 | Substantially Equivalent |
| K810109 | METAL SPLINTS | Jan 26, 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 |