FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATIENT UNDERPAD
K Number: K813263
·
Decision Nov 27, 1981
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
64
Applicant Total
18
Review Days
7
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Basic Information
- Device Name
- PATIENT UNDERPAD
- K Number
- K813263
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6060
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- The Buckeye Cellulose Corp.
- Date Received
- November 20, 1981
- Decision Date
- November 27, 1981
- Product Code
- KME
- 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 |
|---|---|---|---|
| KME | Bedding, Disposable, Medical | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by The Buckeye Cellulose Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K822925 | BOUNDARY SINGLE-USE GOWNS | Jan 12, 1983 | Substantially Equivalent |
| K823173 | ARRIRM SCRUB BRUSH/SPONGE | Nov 22, 1982 | Substantially Equivalent |
| K821564 | BOUNDARY PROCESS CHANGE | Jul 2, 1982 | Substantially Equivalent |
| K820758 | BOUNDARY SINGLE-USE CRANIOTOMY SHEET | Apr 29, 1982 | Substantially Equivalent |
| K820116 | BOUNDARY | Feb 23, 1982 | Substantially Equivalent |
| K813450 | BOUNDARY SINGLE-USE DRAPES | Jan 22, 1982 | Substantially Equivalent |
| K813390 | BONDARY SINGLE-USE OR GOWN | Jan 5, 1982 | Substantially Equivalent |
| K813277 | BOUNDARY DRAPE TAPE | Dec 18, 1981 | Substantially Equivalent |
| K812962 | BOUNDARY SURGICAL DRAPE | Nov 20, 1981 | Substantially Equivalent |
| K812738 | BOUNDARY PROCESS CHANGE | Nov 16, 1981 | Substantially Equivalent |