Pef Tube

FDA 510(k) K071579 · N.M. Beale Co., Inc.

Substantially Equivalent

510(k) numberK071579

Submission

Device name
Pef Tube
Applicant
N.M. Beale Co., Inc.
Ayer, MA, US
Received
June 8, 2007
Decision date
November 20, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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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Questions and answers

When was Pef Tube cleared by the FDA?

Pef Tube (K071579) received a 510(k) decision of Substantially Equivalent on November 20, 2007, 165 days after the submission was received.

What is the product code of K071579?

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