Serenity Contoured Absorbent Shields
FDA 510(k) K840679 · Johnson & Johnson Consumer Products, Inc.
510(k) numberK840679
Submission
- Device name
- Serenity Contoured Absorbent Shields
- Applicant
- Johnson & Johnson Consumer Products, Inc.
Skillman, NJ, US - Received
- February 15, 1984
- Decision date
- March 22, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EYQ – Garment, Protective, For Incontinence
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5920
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K950784 | Dristar Urinary Incontinence Management SystemEYQ · Traditional | Advanced Bioresearch Assoc. | 05/03/1995SE |
| K932310 | Kit Pak Incontinent Skin Care KitEYQ · Traditional | Kit Pak, Inc. | 06/01/1994SEKD |
| K903342 | Deodorizing and Sound Muffling Anal PadEYQ · Traditional | Biological Resistance, Inc. | 10/23/1990SE |
| K891686 | Lib System, Baby/Adult DiaperEYQ · Traditional | Intera Corp. | 05/31/1989SE |
| K885185 | Intera Shield and Intera UndergarmentEYQ · Traditional | Intera Corp. | 02/08/1989SE |
| K883895 | Dripride Ultra Incontinent PadEYQ · Traditional | Weyerhaeuser Co. | 01/30/1989SE |
| K883894 | Dripride Provide SlimEYQ · Traditional | Weyerhaeuser Co. | 01/30/1989SE |
| K883787 | Reusable Adult Incontinent DiaperEYQ · Traditional | Intera Corp. | 11/07/1988SE |
| K882418 | Dry Comfort UndergarmentEYQ · Traditional | Health Tec, Inc. | 09/29/1988SE |
| K880454 | At Ease Stress PadEYQ · Traditional | Hospital Specialty Co. | 06/16/1988SE |
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Questions and answers
When was Serenity Contoured Absorbent Shields cleared by the FDA?
Serenity Contoured Absorbent Shields (K840679) received a 510(k) decision of Substantially Equivalent on March 22, 1984, 36 days after the submission was received.
What is the product code of K840679?
The FDA product code is EYQ – Garment, Protective, For Incontinence, a Class I (low risk) device regulated under 21 CFR 876.5920.