DISPOSABLE BEDPAN
FDA 510(k) clearance K791346 · decided 1979-08-03
Clearance details
- K-number
- K791346
- Device name
- DISPOSABLE BEDPAN
- Applicant
- General Clinical Plastics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-12
- Decision date
- 1979-08-03
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- FOB
- Device class
- 1
- Regulation number
- 880.6730
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STAND UP TOILET (K780370) | Medical Specialty Products, Inc. | 1978-04-10 |
| BEDPAN, GENERAL MEDICAL MEDI-PAK (K760490) | Landmark Plastics | 1976-11-12 |
| BED PAN, STACKABLE (AUTOCLAVABLE) (K760393) | Bemis Health Care | 1976-08-23 |
| BEDPAN, SINGLE PATIENT USE, TECNOL (K760307) | Tecnol New Jersey Wound Care, Inc. | 1976-08-11 |
Recalls involving this device
No recalls on record reference this clearance.