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FDA 510(k)

RACE ENDODONTIC FILE

K-Number: K002709 · 2000-11-17

ApplicantAmc General, Inc.
Decision Date2000-11-17
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RACE ENDODONTIC FILE is the device name listed in this FDA 510(k) record. The listed applicant is Amc General, Inc.. It received FDA 510(k) clearance on 2000-11-17 under 510(k) number K002709. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RACE ENDODONTIC FILE?

RACE ENDODONTIC FILE is a medical device that received FDA 510(k) clearance on 2000-11-17. The listed applicant is Amc General, Inc.. The 510(k) number is K002709.

When did RACE ENDODONTIC FILE receive FDA 510(k) clearance?

RACE ENDODONTIC FILE received FDA 510(k) clearance on 2000-11-17, under 510(k) number K002709.

Who is the listed applicant for RACE ENDODONTIC FILE?

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

What is the FDA product code for RACE ENDODONTIC FILE?

The FDA product code for RACE ENDODONTIC FILE is EFA.

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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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