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FDA 510(k)

UNIVERSITY PLATE ANTERIOR SYSTEM

K-Number: K980228 · 1998-04-14

ApplicantAcromed Corp.
Decision Date1998-04-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

UNIVERSITY PLATE ANTERIOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acromed Corp.. It received FDA 510(k) clearance on 1998-04-14 under 510(k) number K980228. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the UNIVERSITY PLATE ANTERIOR SYSTEM?

UNIVERSITY PLATE ANTERIOR SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-14. The listed applicant is Acromed Corp.. The 510(k) number is K980228.

When did UNIVERSITY PLATE ANTERIOR SYSTEM receive FDA 510(k) clearance?

UNIVERSITY PLATE ANTERIOR SYSTEM received FDA 510(k) clearance on 1998-04-14, under 510(k) number K980228.

Who is the listed applicant for UNIVERSITY PLATE ANTERIOR SYSTEM?

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

What is the FDA product code for UNIVERSITY PLATE ANTERIOR SYSTEM?

The FDA product code for UNIVERSITY PLATE ANTERIOR SYSTEM is KWQ.

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Other records listing Acromed Corp. as applicant

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Related Devices (Code: KWQ)

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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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