STANDARD RUBBER DAM WITH OR WITHOUT FRAMES— 510(k) K905470

Name: FDA 510(k) clearance K905470
Creator: U.S. Food and Drug Administration
Published: 1991-04-25

Substantially Equivalent

Elastomade Accessories Sdn Bhd

FDA 510(k) clearance K905470 for STANDARD RUBBER DAM WITH OR WITHOUT FRAMES, Substantially Equivalent on 1991-04-25. Applicant: Elastomade Accessories Sdn Bhd. Device class: 1.

Clearance details

Applicant: Elastomade Accessories Sdn Bhd
Product code: Code EIE
Device class: Class 1
Regulation: 21 CFR 872.6300
Advisory panel: Dental
Date received: 1990-12-06
Decision date: 1991-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaling Jaya, MY

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