Hollister Feeding Tube Attachment Device

FDA 510(k) K893888 · Hollister, Inc.

Substantially Equivalent

510(k) numberK893888

Submission

Device name
Hollister Feeding Tube Attachment Device
Applicant
Hollister, Inc.
Libertyville, IL, US
Received
May 30, 1989
Decision date
October 17, 1989
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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Questions and answers

When was Hollister Feeding Tube Attachment Device cleared by the FDA?

Hollister Feeding Tube Attachment Device (K893888) received a 510(k) decision of Substantially Equivalent on October 17, 1989, 140 days after the submission was received.

What is the product code of K893888?

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