ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS— 510(k) K952628

Name: FDA 510(k) clearance K952628
Creator: U.S. Food and Drug Administration
Published: 1995-10-19

Substantially Equivalent

Elastomade Accessories Sdn Bhd

FDA 510(k) clearance K952628 for ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS, Substantially Equivalent on 1995-10-19. 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: 1995-06-08
Decision date: 1995-10-19
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.