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FDA 510(k)

SILVERFIL

K-Number: K053114 · 2005-11-15

ApplicantDunia Perwira Manufacturing Sdn. Bhd.
Decision Date2005-11-15
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILVERFIL is the device name listed in this FDA 510(k) record. The listed applicant is Dunia Perwira Manufacturing Sdn. Bhd.. It received FDA 510(k) clearance on 2005-11-15 under 510(k) number K053114. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILVERFIL?

SILVERFIL is a medical device that received FDA 510(k) clearance on 2005-11-15. The listed applicant is Dunia Perwira Manufacturing Sdn. Bhd.. The 510(k) number is K053114.

When did SILVERFIL receive FDA 510(k) clearance?

SILVERFIL received FDA 510(k) clearance on 2005-11-15, under 510(k) number K053114.

Who is the listed applicant for SILVERFIL?

The FDA 510(k) record lists Dunia Perwira Manufacturing Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILVERFIL?

The FDA product code for SILVERFIL is EJJ.

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Related Devices (Code: EJJ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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