BK-1129 Bottle Straw
FDA 510(k) K813630 · Fred Sammons, Inc.
510(k) numberK813630
Submission
- Device name
- BK-1129 Bottle Straw
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- December 29, 1981
- Decision date
- January 19, 1982
- 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 |
|---|---|---|---|
| K833177 | Glossectomy Feeding SpoonsILC · Traditional | Maddak, Inc. | 10/31/1983SE |
| 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 |
| 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 |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
Questions and answers
When was BK-1129 Bottle Straw cleared by the FDA?
BK-1129 Bottle Straw (K813630) received a 510(k) decision of Substantially Equivalent on January 19, 1982, 21 days after the submission was received.
What is the product code of K813630?
The FDA product code is ILC – Utensil, Eating, a Class I (low risk) device regulated under 21 CFR 890.5050.