Plastic Break Resistant Mirror
FDA 510(k) K823606 · Fred Sammons, Inc.
510(k) numberK823606
Submission
- Device name
- Plastic Break Resistant Mirror
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- December 6, 1982
- Decision date
- December 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILS – Adaptor, Hygiene
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5050
- Specialty
- Physical Medicine
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| K830852 | Shower Stool W/HandlesILS · Traditional | Lic-Orthion | 04/05/1983SE |
| K823641 | Bathing Chair for ChildILS · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823626 | Disposable Tooth BrushILS · Traditional | Fred Sammons, Inc. | 12/30/1982SE |
| K823156 | Collapsable Lavatory HeightenerILS · Traditional | Orthion Corp. | 11/05/1982SE |
| K823155 | Lavatory Seat HeightenerILS · Traditional | Orthion Corp. | 11/05/1982SE |
More from Orthion Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
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| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
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| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
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| 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 |
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Questions and answers
When was Plastic Break Resistant Mirror cleared by the FDA?
Plastic Break Resistant Mirror (K823606) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 22 days after the submission was received.
What is the product code of K823606?
The FDA product code is ILS – Adaptor, Hygiene, a Class I (low risk) device regulated under 21 CFR 890.5050.