BUILT-UP HANDLE UTENSILS
FDA 510(k) clearance K761113 · decided 1976-12-02
Clearance details
- K-number
- K761113
- Device name
- BUILT-UP HANDLE UTENSILS
- Applicant
- Fred Sammons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-11-19
- Decision date
- 1976-12-02
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- ILC
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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 |
|---|---|---|
| GLOSSECTOMY FEEDING SPOONS (K833177) | Maddak, Inc. | 1983-10-31 |
| COLLAPSABLE LAVATORY SEAT HEIGHTENER (K830854) | Lic-Orthion | 1983-04-05 |
| BATH TUB SEAT & BATH BOARD (K830851) | Lic-Orthion | 1983-04-05 |
| PLASTIC BUILT-UP HANDLE EATING UTENSILS (K823594) | Fred Sammons, Inc. | 1982-12-22 |
| EATING UTENSILS (K821643) | Fred Sammons, Inc. | 1982-06-11 |
| BK-1129 BOTTLE STRAW (K813630) | Fred Sammons, Inc. | 1982-01-19 |
| ALUMINUM SCOOP DISK (K812346) | Fred Sammons, Inc. | 1981-09-11 |
| FEEDING AID KIT (K811488) | Fred Sammons, Inc. | 1981-06-12 |
| EATING UTENSILS (K810455) | Fred Sammons, Inc. | 1981-03-04 |
| BK-1426-00-01 STONYBROOK/HI-WALL PLATE (K801706) | Fred Sammons, Inc. | 1980-08-07 |
| BK-1424 INNER LIP PLATE, CERAMIC (K801705) | Fred Sammons, Inc. | 1980-08-07 |
| BK-1544 BE OK SCOOP DISK (K800019) | Fred Sammons, Inc. | 1980-01-21 |
Recalls involving this device
No recalls on record reference this clearance.