Effner Fe-Ex* Orogastric

FDA 510(k) K874755 · Effner and Spreine Co.

Substantially Equivalent

510(k) numberK874755

Submission

Device name
Effner Fe-Ex* Orogastric
Applicant
Effner and Spreine Co.
Port Washington, NY, US
Received
November 18, 1987
Decision date
April 6, 1988
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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More from Degania Silicone , Ltd.

510(k)DeviceDecision
K875260Effner Cautery InstrumentsHQP · Traditional 06/06/1988SE
K872480Kahn-Tact U.S.A., Eff LaryngoscopeCCW · Traditional 08/10/1987SE
K852014Effner Sims Rectal Speculum W/Fiber Optic IlluminaKOA · Traditional 08/07/1985SE

Questions and answers

When was Effner Fe-Ex* Orogastric cleared by the FDA?

Effner Fe-Ex* Orogastric (K874755) received a 510(k) decision of Substantially Equivalent on April 6, 1988, 140 days after the submission was received.

What is the product code of K874755?

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