Karaya Gum Powder

FDA 510(k) K770230 · Atlantic Surgical

Substantially Equivalent

510(k) numberK770230

Submission

Device name
Karaya Gum Powder
Applicant
Atlantic Surgical
Mchenry, IL, US
Received
February 7, 1977
Decision date
February 28, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EZR – Cement, Stomal Appliance, Ostomy
Device class
Class I (low risk)
Regulation
21 CFR 876.5900
Specialty
Gastroenterology, Urology

Other 510(k)s with product code EZR

510(k)DeviceApplicantDecision
K844341United Skin Barrier PasteEZR · Traditional Howmedica Corp.01/18/1985SE
K803100Stomahesive Paste Protective Skin BarrEZR · Traditional E. R. Squibb & Sons, Inc.01/08/1981SE
K791146Colo-TapeEZR · Traditional Suburban Ostomy Supply Co., Inc.07/30/1979SE
K761340Ostomy Karaya Gum PowderEZR · Traditional Howmedica Corp.03/07/1977SE
K761319Karaya Gum Products - Process ChangeEZR · Traditional Howmedica Corp.02/15/1977SE

More from Howmedica Corp.

510(k)DeviceDecision
K820167Laminated Karaya Gum WashersEXB · Traditional 02/18/1982SE
K772366Bag, Drainagew/Adhesive; ProsthesisFON · Traditional 01/26/1978SE

Questions and answers

When was Karaya Gum Powder cleared by the FDA?

Karaya Gum Powder (K770230) received a 510(k) decision of Substantially Equivalent on February 28, 1977, 21 days after the submission was received.

What is the product code of K770230?

The FDA product code is EZR – Cement, Stomal Appliance, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.