Chicopee Adult Incontinence Shields
FDA 510(k) K880338 · Chicopee, Inc.
510(k) numberK880338
Submission
- Device name
- Chicopee Adult Incontinence Shields
- Applicant
- Chicopee, Inc.
Dayton, NJ, US - Received
- January 26, 1988
- Decision date
- March 31, 1988
- 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
Other 510(k)s with product code EYQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Chicopee Adult Incontinence Shields cleared by the FDA?
Chicopee Adult Incontinence Shields (K880338) received a 510(k) decision of Substantially Equivalent on March 31, 1988, 65 days after the submission was received.
What is the product code of K880338?
The FDA product code is EYQ – Garment, Protective, For Incontinence, a Class I (low risk) device regulated under 21 CFR 876.5920.