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FDA 510(k)

ACCU-BITE HOME KIT DISCLUDER

K-Number: K980953 · 1998-10-07

ApplicantJerome M. Simon
Decision Date1998-10-07
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

ACCU-BITE HOME KIT DISCLUDER is the device name listed in this FDA 510(k) record. The listed applicant is Jerome M. Simon. It received FDA 510(k) clearance on 1998-10-07 under 510(k) number K980953. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-BITE HOME KIT DISCLUDER?

ACCU-BITE HOME KIT DISCLUDER is a medical device that received FDA 510(k) clearance on 1998-10-07. The listed applicant is Jerome M. Simon. The 510(k) number is K980953.

When did ACCU-BITE HOME KIT DISCLUDER receive FDA 510(k) clearance?

ACCU-BITE HOME KIT DISCLUDER received FDA 510(k) clearance on 1998-10-07, under 510(k) number K980953.

Who is the listed applicant for ACCU-BITE HOME KIT DISCLUDER?

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

What is the FDA product code for ACCU-BITE HOME KIT DISCLUDER?

The FDA product code for ACCU-BITE HOME KIT DISCLUDER is MQC.

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Related Devices (Code: MQC)

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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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