P.A. Medical Vaginal Irrigation Set #1130

FDA 510(k) K854595 · Pa Medical Corp.

Substantially Equivalent

510(k) numberK854595

Submission

Device name
P.A. Medical Vaginal Irrigation Set #1130
Applicant
Pa Medical Corp.
Columbia, TN, US
Received
November 18, 1985
Decision date
January 13, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HED – Douche Apparatus, Vaginal, Therapeutic
Device class
Class I (low risk)
Regulation
21 CFR 884.5900
Specialty
Obstetrics/Gynecology

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K000736La JoieHED · Traditional Goomi Ehwa, Inc.08/08/2000SE
K902830Peri-BottleHED · Traditional Orion Life Systems, Inc.08/06/1990SE
K881216Gent-L-Kare Vaginal Irrigation SetHED · Traditional Geneva Laboratories, Inc.06/07/1988SE
K841710Mac Lee Vaginal IrrigatorHED · Traditional Mac Lee Medical Products06/19/1984SE
K831667Feminine Hygiene DeviceHED · Traditional Snow Willow Co.09/12/1983SE
K800956Douch Tray-Disposable Vaginal Tray W/BenHED · Traditional The Healthcare Group Laboratories, Inc.10/03/1980SE
K800954Douche Tray-Dispos. Vaginal Tray W/PovidHED · Traditional The Healthcare Group Laboratories, Inc.10/03/1980SE
K800957Douche UNIT-1500 ML Disp. ContainerHED · Traditional The Healthcare Group Laboratories, Inc.07/14/1980SE

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K871449Oncology SPT Sys #MS-C10 Medication Reservoir BagKPE · Traditional 06/17/1987SE
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K853309P.A. Enteral Feeding Bag 1100KNT · Traditional 08/27/1985SE

Questions and answers

When was P.A. Medical Vaginal Irrigation Set #1130 cleared by the FDA?

P.A. Medical Vaginal Irrigation Set #1130 (K854595) received a 510(k) decision of Substantially Equivalent on January 13, 1986, 56 days after the submission was received.

What is the product code of K854595?

The FDA product code is HED – Douche Apparatus, Vaginal, Therapeutic, a Class I (low risk) device regulated under 21 CFR 884.5900.