FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ODOR MASKING AGENT IN BOUNDARY OBSTETRI.
K Number: K801024
·
Decision Jul 28, 1980
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
56
Applicant Total
18
Review Days
91
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Basic Information
- Device Name
- ODOR MASKING AGENT IN BOUNDARY OBSTETRI.
- K Number
- K801024
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- The Buckeye Cellulose Corp.
- Date Received
- April 28, 1980
- Decision Date
- July 28, 1980
- Product Code
- HHL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHL), ordered by most recent decision date.
DEODORANT MAXI PAD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEODORANT PANTY LINER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEODORANT PANTY SHIELD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAREFREE PANTYLINERS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALWAYS, UNSCENTED MENSTRUAL PAD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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 |