FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BOUNDARY TUBING HOLDERS
K Number: K810888
·
Decision Apr 23, 1981
Classifications
1
FEI Numbers
526
Registration Numbers
526
Same Product Code
18
Applicant Total
18
Review Days
21
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Basic Information
- Device Name
- BOUNDARY TUBING HOLDERS
- K Number
- K810888
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- The Buckeye Cellulose Corp.
- Date Received
- April 2, 1981
- Decision Date
- April 23, 1981
- Product Code
- FZX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FZX | Guide, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZX), ordered by most recent decision date.
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MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY
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NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
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·General, Plastic Surgery
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 |
| K813263 | PATIENT UNDERPAD | Nov 27, 1981 | Substantially Equivalent |
| K812962 | BOUNDARY SURGICAL DRAPE | Nov 20, 1981 | Substantially Equivalent |