Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal— 510(k) K192042

Name: FDA 510(k) clearance K192042
Creator: U.S. Food and Drug Administration
Published: 2019-08-29

Substantially Equivalent

Geistlich Pharma AG

FDA 510(k) clearance K192042 for Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal, Substantially Equivalent on 2019-08-29. Applicant: Geistlich Pharma AG. Device class: 2.

Clearance details

Applicant: Geistlich Pharma AG
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2019-07-31
Decision date: 2019-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Wolhusen, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.