FDA · official record K042197Substantially Equivalent

BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION

Name: BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION — FDA K042197
Creator: Ed. Geistlich Soehne AG Fuer Chemische Industrie
Keywords: BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION, BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION, K042197, NPL, FDA

United StatesNPLEd. Geistlich Soehne AG Fuer Chemische Industrie

Verified

Official record identity

FDA application number: K042197
Decision date: November 15, 2004
Published decision: Substantially Equivalent

Classification

Product code: NPL

Published parties

Applicant: Ed. Geistlich Soehne AG Fuer Chemische Industrie

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2004-08-13
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3930

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.