FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELASTIC BANDAGE
K Number: K802785
·
Decision Dec 11, 1980
Classifications
1
FEI Numbers
681
Registration Numbers
681
Same Product Code
41
Applicant Total
18
Review Days
37
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Basic Information
- Device Name
- ELASTIC BANDAGE
- K Number
- K802785
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Secol Co.
- Date Received
- November 4, 1980
- Decision Date
- December 11, 1980
- Product Code
- FQM
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FQM | Bandage, Elastic | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FQM), ordered by most recent decision date.
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
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FDA Class 1
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BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
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FDA Class 1
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COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
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FDA Class 1
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SKIN SAVER SYSTEMS
FDA 510(k)
FDA Class 1
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ASPEN ESMARK BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
TUBE-BANDAGE FOR HUMAN DIGITS 200
FDA 510(k)
FDA Class 1
·General Hospital
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 |