Douche UNIT-1500 ML Disp. Container
FDA 510(k) K800957 · The Healthcare Group Laboratories, Inc.
510(k) numberK800957
Submission
- Device name
- Douche UNIT-1500 ML Disp. Container
- Applicant
- The Healthcare Group Laboratories, Inc.
Mchenry, IL, US - Received
- April 23, 1980
- Decision date
- July 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HED – Douche Apparatus, Vaginal, Therapeutic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.5900
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080200 | Water Works Douching DeviceHED · Traditional | Abbott Research Group, Inc. | 07/10/2008SE |
| K030056 | Worry-Remover IrrigatorHED · Traditional | Corisen Group, Ltd. | 04/22/2003SE |
| K000736 | La JoieHED · Traditional | Goomi Ehwa, Inc. | 08/08/2000SE |
| K902830 | Peri-BottleHED · Traditional | Orion Life Systems, Inc. | 08/06/1990SE |
| K881216 | Gent-L-Kare Vaginal Irrigation SetHED · Traditional | Geneva Laboratories, Inc. | 06/07/1988SE |
| K854595 | P.A. Medical Vaginal Irrigation Set #1130HED · Traditional | Pa Medical Corp. | 01/13/1986SE |
| K841710 | Mac Lee Vaginal IrrigatorHED · Traditional | Mac Lee Medical Products | 06/19/1984SE |
| K831667 | Feminine Hygiene DeviceHED · Traditional | Snow Willow Co. | 09/12/1983SE |
| K800956 | Douch Tray-Disposable Vaginal Tray W/BenHED · Traditional | The Healthcare Group Laboratories, Inc. | 10/03/1980SE |
| K800954 | Douche Tray-Dispos. Vaginal Tray W/PovidHED · Traditional | The Healthcare Group Laboratories, Inc. | 10/03/1980SE |
More from The Healthcare Group Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850035 | Empty Solution Transfer ContainerKPE · Traditional | 06/07/1985SE |
| K842170 | Empty Solution Transfer ContainerKPE · Traditional | 10/19/1984SE |
| K842091 | Dispos. Acu-Cut Soft Tissue Biopsy · Traditional | 07/23/1984SE |
| K840742 | Right Atrial CatheterLJS · Traditional | 07/13/1984SE |
| K830299 | Solution Transfer ContainerKPE · Traditional | 02/19/1983SE |
| K822307 | Adhesive Spray #4050-4060KNX · Traditional | 09/24/1982SE |
| K822059 | Show'RbagLGF · Traditional | 07/22/1982SE |
| K821480 | Right Atrial Catheters Parenteral NutritDQY · Traditional | 06/17/1982SE |
| K821230 | Softic 49EBI · Traditional | 05/28/1982SE |
| K821162 | Adhesive RemoverKOX · Traditional | 05/14/1982SE |
Questions and answers
When was Douche UNIT-1500 ML Disp. Container cleared by the FDA?
Douche UNIT-1500 ML Disp. Container (K800957) received a 510(k) decision of Substantially Equivalent on July 14, 1980, 82 days after the submission was received.
What is the product code of K800957?
The FDA product code is HED – Douche Apparatus, Vaginal, Therapeutic, a Class I (low risk) device regulated under 21 CFR 884.5900.