Norta

FDA 510(k) K935630 · Beiersdorf, Inc.

Substantially Equivalent

510(k) numberK935630

Submission

Device name
Norta
Applicant
Beiersdorf, Inc.
Norwalk, CT, US
Received
November 23, 1993
Decision date
October 7, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EZL – Catheter, Retention Type, Balloon
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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Questions and answers

When was Norta cleared by the FDA?

Norta (K935630) received a 510(k) decision of Substantially Equivalent on October 7, 1994, 318 days after the submission was received.

What is the product code of K935630?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.