FDA · official record K900631Substantially Equivalent

SALIVA ABSORBER - DENTAL

Name: SALIVA ABSORBER - DENTAL — FDA K900631
Creator: Kab Gloves Unltd.
Keywords: SALIVA ABSORBER - DENTAL, SALIVA ABSORBER - DENTAL, K900631, DYN, FDA

United StatesDYNKab Gloves Unltd.

Verified

Official record identity

FDA application number: K900631
Decision date: April 04, 1990
Published decision: Substantially Equivalent

Classification

Product code: DYN

Published parties

Applicant: Kab Gloves Unltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1990-02-08
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

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.