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FDA 510(k)

MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES

K-Number: K913175 · 1991-12-27

ApplicantG-C Intl. Corp.
Decision Date1991-12-27
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES is the device name listed in this FDA 510(k) record. The listed applicant is G-C Intl. Corp.. It received FDA 510(k) clearance on 1991-12-27 under 510(k) number K913175. 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 MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES?

MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES is a medical device that received FDA 510(k) clearance on 1991-12-27. The listed applicant is G-C Intl. Corp.. The 510(k) number is K913175.

When did MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES receive FDA 510(k) clearance?

MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES received FDA 510(k) clearance on 1991-12-27, under 510(k) number K913175.

Who is the listed applicant for MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES?

The FDA 510(k) record lists G-C Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES?

The FDA product code for MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES is EJJ.

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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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