Fluid Dispensing System

FDA 510(k) K800362 · Pharmaseal Laboratories

Substantially Equivalent

510(k) numberK800362

Submission

Device name
Fluid Dispensing System
Applicant
Pharmaseal Laboratories
Mchenry, IL, US
Received
February 20, 1980
Decision date
March 12, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KYX – Dispenser, Liquid Medication
Device class
Class I (low risk)
Regulation
21 CFR 880.6430
Specialty
General Hospital

Other 510(k)s with product code KYX

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K143177KleenGel DispenserKYX · Traditional Kleengel, LLC09/14/2015SE
K980109Cyclotech Cyclosporine Oral Solutions DispenserKYX · Traditional Sangstat Medical Corp.08/18/1998SE
K954181Canyons Bi-Directional Check ValveKYX · Traditional Canyon Medical Products11/29/1995SE
K830571Bottle AdapterKYX · Traditional Burron Medical Products, Inc.03/24/1983SE
K801008Multi-Ad Fluid Dispensing Pump MP-3000KYX · Traditional Burron Medical Products, Inc.06/02/1980SE
K800437Syringe Tip ConnectorKYX · Traditional Burron Medical Products, Inc.03/12/1980SE
K792227Multi-Ad Fluid Dispensing SystemKYX · Traditional National Patent Development Corp.12/20/1979SE
K781364Pint Bottle WellKYX · Traditional Baxa Corp., Sub. of Cook Group, Inc.10/17/1978SE
K771539StepperKYX · Traditional Tridak10/07/1977SE
K760517Cup, Disposable MedicineKYX · Traditional Landmark Plastics11/12/1976SE

More from Landmark Plastics

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K800737Debrisan (Dextranomer) PasteKOZ · Traditional 08/04/1980SE
K801146Sampling KitCBT · Traditional 06/04/1980SE
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K760469Cleansing Agent, New Wound (Debrissu)KOZ · Traditional 12/16/1976SE

Questions and answers

When was Fluid Dispensing System cleared by the FDA?

Fluid Dispensing System (K800362) received a 510(k) decision of Substantially Equivalent on March 12, 1980, 21 days after the submission was received.

What is the product code of K800362?

The FDA product code is KYX – Dispenser, Liquid Medication, a Class I (low risk) device regulated under 21 CFR 880.6430.