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FDA 510(k)

PRIMOSPLINT SYSTEM

K-Number: K030832 · 2003-09-17

ApplicantCosmedent, Inc.
Decision Date2003-09-17
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

PRIMOSPLINT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 2003-09-17 under 510(k) number K030832. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMOSPLINT SYSTEM?

PRIMOSPLINT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-17. The listed applicant is Cosmedent, Inc.. The 510(k) number is K030832.

When did PRIMOSPLINT SYSTEM receive FDA 510(k) clearance?

PRIMOSPLINT SYSTEM received FDA 510(k) clearance on 2003-09-17, under 510(k) number K030832.

Who is the listed applicant for PRIMOSPLINT SYSTEM?

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

What is the FDA product code for PRIMOSPLINT SYSTEM?

The FDA product code for PRIMOSPLINT SYSTEM is MQC.

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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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