FDA · official record K891054Substantially Equivalent

NON-STERILE GAUZE SPONGE

Name: NON-STERILE GAUZE SPONGE — FDA K891054
Creator: Dispomed, Inc.
Keywords: NON-STERILE GAUZE SPONGE, NON-STERILE GAUZE SPONGE, K891054, KHR, FDA

United StatesKHRDispomed, Inc.

Verified

Official record identity

FDA application number: K891054
Decision date: May 01, 1989
Published decision: Substantially Equivalent

Classification

Product code: KHR

Published parties

Applicant: Dispomed, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1989-02-27
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6050

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.