FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPRATEX ABDOMINAL PAD
K Number: K802798
·
Decision Dec 11, 1980
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
18
Review Days
37
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Basic Information
- Device Name
- OPRATEX ABDOMINAL PAD
- K Number
- K802798
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Secol Co.
- Date Received
- November 4, 1980
- Decision Date
- December 11, 1980
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
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KENSORB
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TRIANGULAR SPONGES
FDA 510(k)
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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 |
| 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 |