FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUBULAR STOCKINETTE
K Number: K820142
·
Decision Feb 5, 1982
Classifications
1
FEI Numbers
681
Registration Numbers
681
Same Product Code
41
Applicant Total
20
Review Days
17
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Basic Information
- Device Name
- TUBULAR STOCKINETTE
- K Number
- K820142
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Stan-Pak Ent.
- Date Received
- January 19, 1982
- Decision Date
- February 5, 1982
- 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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SKIN SAVER SYSTEMS
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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
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Other Clearances by Stan-Pak Ent.
| K Number | Device Name | ||
|---|---|---|---|
| K823058 | DOSOMETRIC RELEASE STERILIZATION | Dec 9, 1982 | Substantially Equivalent |
| K820100 | FROSTED GLASS SLIDES | Mar 4, 1982 | Substantially Equivalent |
| K820099 | TRACH TAPE | Feb 23, 1982 | Substantially Equivalent |
| K820140 | WEBRIL CAST PADDING | Feb 12, 1982 | Substantially Equivalent |
| K820108 | TOPPER SPONGES | Feb 12, 1982 | Substantially Equivalent |
| K820155 | SPECIALIST CAST PADDING | Feb 12, 1982 | Substantially Equivalent |
| K820106 | X-RAY GUAZE SPONGES | Feb 12, 1982 | Substantially Equivalent |
| K820107 | GUAZE SPONGES, PLAIN | Feb 12, 1982 | Substantially Equivalent |
| K820056 | TELFA STRIPS | Feb 5, 1982 | Substantially Equivalent |
| K820139 | SOF-ROL CAST PADDING | Feb 5, 1982 | Substantially Equivalent |