ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)— 510(k) K972889

Name: FDA 510(k) clearance K972889
Creator: U.S. Food and Drug Administration
Published: 1998-01-22

Substantially Equivalent

W & H Dentalwerk

FDA 510(k) clearance K972889 for ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION), Substantially Equivalent on 1998-01-22. Applicant: W & H Dentalwerk. Device class: 1.

Clearance details

Applicant: W & H Dentalwerk
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 1997-08-05
Decision date: 1998-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burmoos, AT

Download summary PDF View on FDA.gov ↗

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