Glossectomy Feeding Spoons
FDA 510(k) K833177 · Maddak, Inc.
510(k) numberK833177
Submission
- Device name
- Glossectomy Feeding Spoons
- Applicant
- Maddak, Inc.
Mchenry, IL, US - Received
- September 19, 1983
- Decision date
- October 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILC – Utensil, Eating
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5050
- Specialty
- Physical Medicine
Other 510(k)s with product code ILC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K830854 | Collapsable Lavatory Seat HeightenerILC · Traditional | Lic-Orthion | 04/05/1983SE |
| K830851 | Bath Tub Seat & Bath BoardILC · Traditional | Lic-Orthion | 04/05/1983SE |
| K823594 | Plastic Built-Up Handle Eating UtensilsILC · Traditional | Fred Sammons, Inc. | 12/22/1982SE |
| K821643 | Eating UtensilsILC · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
| K813630 | BK-1129 Bottle StrawILC · Traditional | Fred Sammons, Inc. | 01/19/1982SE |
| K812346 | Aluminum Scoop DiskILC · Traditional | Fred Sammons, Inc. | 09/11/1981SE |
| K811488 | Feeding Aid KitILC · Traditional | Fred Sammons, Inc. | 06/12/1981SE |
| K810455 | Eating UtensilsILC · Traditional | Fred Sammons, Inc. | 03/04/1981SE |
| K801706 | BK-1426-00-01 Stonybrook/Hi-Wall PlateILC · Traditional | Fred Sammons, Inc. | 08/07/1980SE |
| K801705 | BK-1424 Inner Lip Plate, CeramicILC · Traditional | Fred Sammons, Inc. | 08/07/1980SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841700 | Walk & RollINM · Traditional | 05/11/1984SE |
| K841698 | Heat PackIMA · Traditional | 05/10/1984SE |
| K841695 | CrawlerKNL · Traditional | 05/10/1984SE |
| K841697 | Hydro-Thero PadIRT · Traditional | 05/09/1984SE |
| K841693 | Standing Frame · Traditional | 05/09/1984SE |
| K841692 | Prone Stander · Traditional | 05/09/1984SE |
| K841691 | Split Seat Positioning ChairINN · Traditional | 05/09/1984SE |
| K834311 | Night TrainerKPN · Traditional | 03/30/1984SE |
| K833870 | Knee WalkerION · Traditional | 11/29/1983SE |
| K833090 | Sensory Roller MassagerISA · Traditional | 10/14/1983SE |
Questions and answers
When was Glossectomy Feeding Spoons cleared by the FDA?
Glossectomy Feeding Spoons (K833177) received a 510(k) decision of Substantially Equivalent on October 31, 1983, 42 days after the submission was received.
What is the product code of K833177?
The FDA product code is ILC – Utensil, Eating, a Class I (low risk) device regulated under 21 CFR 890.5050.