Corpak Enteral Sol Adm Pump Set W/ Screw

FDA 510(k) K852792 · Corpak Co.

Substantially Equivalent

510(k) numberK852792

Submission

Device name
Corpak Enteral Sol Adm Pump Set W/ Screw
Applicant
Corpak Co.
Wheeling, IL, US
Received
July 1, 1985
Decision date
August 8, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNT – Tubes, Gastrointestinal (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

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K944750Corflo 300 PumpFRN · Traditional 06/19/1995PT
K931921Corpak Gastrostomy TubeKNT · Traditional 06/09/1995SE
K932847Corpak Enteral PumpFRN · Traditional 06/17/1994ST
K902949Corpak Grasping ForcepsOCZ · Traditional 08/30/1990SE
K901501Corpak Gastrostomy TubeKGC · Traditional 06/11/1990SE
K882867Corpak Percutaneous Endoscopic Gastrostomy TubeKNT · Traditional 09/21/1988SE
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Questions and answers

When was Corpak Enteral Sol Adm Pump Set W/ Screw cleared by the FDA?

Corpak Enteral Sol Adm Pump Set W/ Screw (K852792) received a 510(k) decision of Substantially Equivalent on August 8, 1985, 38 days after the submission was received.

What is the product code of K852792?

The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.