Vacuum Suction Filter

FDA 510(k) K812139 · K & G Healthcare Ind., Inc.

Substantially Equivalent

510(k) numberK812139

Submission

Device name
Vacuum Suction Filter
Applicant
K & G Healthcare Ind., Inc.
Mchenry, IL, US
Received
July 28, 1981
Decision date
August 20, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KDQ – Bottle, Collection, Vacuum
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Specialty
General Hospital

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More from Davol, Inc.

510(k)DeviceDecision
K812573Spirometer FilterCAH · Traditional 10/23/1981SE
K811546Nicholas II, Viral-Bacterial FilterCAH · Traditional 08/03/1981SE

Questions and answers

When was Vacuum Suction Filter cleared by the FDA?

Vacuum Suction Filter (K812139) received a 510(k) decision of Substantially Equivalent on August 20, 1981, 23 days after the submission was received.

What is the product code of K812139?

The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.