FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BEDPAN, GENERAL MEDICAL MEDI-PAK
K Number: K760490
·
Decision Nov 12, 1976
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
4
Applicant Total
13
Review Days
81
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Basic Information
- Device Name
- BEDPAN, GENERAL MEDICAL MEDI-PAK
- K Number
- K760490
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6730
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Landmark Plastics
- Date Received
- August 23, 1976
- Decision Date
- November 12, 1976
- Product Code
- FOB
- 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 |
|---|---|---|---|
| FOB | Bedpan | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOB), ordered by most recent decision date.
DISPOSABLE BEDPAN
FDA 510(k)
FDA Class 1
·General Hospital
STAND UP TOILET
FDA 510(k)
FDA Class 1
·General Hospital
BED PAN, STACKABLE (AUTOCLAVABLE)
FDA 510(k)
FDA Class 1
·General Hospital
BEDPAN, SINGLE PATIENT USE, TECNOL
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Landmark Plastics
| K Number | Device Name | ||
|---|---|---|---|
| K760496 | CUP, DISPOSABLE SPECIMEN | Nov 12, 1976 | Substantially Equivalent |
| K760493 | DISH, SOAP | Nov 12, 1976 | Substantially Equivalent |
| K760492 | BASIN, LARGE OR SMALL | Nov 12, 1976 | Substantially Equivalent |
| K760552 | THERMOMETER STAND AND DUST COVER | Nov 12, 1976 | Substantially Equivalent |
| K760494 | BASIN, ROUND WASH | Nov 12, 1976 | Substantially Equivalent |
| K760517 | CUP, DISPOSABLE MEDICINE | Nov 12, 1976 | Substantially Equivalent |
| K760497 | TRAY, SERVICE | Nov 12, 1976 | Substantially Equivalent |
| K760495 | BASIN, RECTANGULAR WASH | Nov 12, 1976 | Substantially Equivalent |
| K760548 | CARAFE AND LINER | Nov 12, 1976 | Substantially Equivalent |
| K760491 | TUMBLER, GENERAL MEDICAL MEDI-PAK | Sep 15, 1976 | Substantially Equivalent |