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FDA 510(k)

PERMACEM / PERMACEM DUAL

K-Number: K012316 · 2001-08-23

ApplicantDmg USA, Inc.
Decision Date2001-08-23
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMACEM / PERMACEM DUAL is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2001-08-23 under 510(k) number K012316. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMACEM / PERMACEM DUAL?

PERMACEM / PERMACEM DUAL is a medical device that received FDA 510(k) clearance on 2001-08-23. The listed applicant is Dmg USA, Inc.. The 510(k) number is K012316.

When did PERMACEM / PERMACEM DUAL receive FDA 510(k) clearance?

PERMACEM / PERMACEM DUAL received FDA 510(k) clearance on 2001-08-23, under 510(k) number K012316.

Who is the listed applicant for PERMACEM / PERMACEM DUAL?

The FDA 510(k) record lists Dmg USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERMACEM / PERMACEM DUAL?

The FDA product code for PERMACEM / PERMACEM DUAL is EMA.

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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