FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOUNDARY PROCESS CHANGE
K Number: K821564
·
Decision Jul 2, 1982
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
18
Review Days
38
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Basic Information
- Device Name
- BOUNDARY PROCESS CHANGE
- K Number
- K821564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- The Buckeye Cellulose Corp.
- Date Received
- May 25, 1982
- Decision Date
- July 2, 1982
- Product Code
- FYA
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |
| K813263 | PATIENT UNDERPAD | Nov 27, 1981 | Substantially Equivalent |
| K812962 | BOUNDARY SURGICAL DRAPE | Nov 20, 1981 | Substantially Equivalent |
| K812738 | BOUNDARY PROCESS CHANGE | Nov 16, 1981 | Substantially Equivalent |