FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECIALIST CAST PADDING
K Number: K820155
·
Decision Feb 12, 1982
Classifications
1
FEI Numbers
239
Registration Numbers
239
Same Product Code
36
Applicant Total
20
Review Days
24
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Basic Information
- Device Name
- SPECIALIST CAST PADDING
- K Number
- K820155
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Stan-Pak Ent.
- Date Received
- January 19, 1982
- Decision Date
- February 12, 1982
- Product Code
- ITG
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ITG | Bandage, Cast | FDA class 1 | Physical Medicine |
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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 |
| 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 |
| K820142 | TUBULAR STOCKINETTE | Feb 5, 1982 | Substantially Equivalent |
| K820139 | SOF-ROL CAST PADDING | Feb 5, 1982 | Substantially Equivalent |