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FDA 510(k)

3MM DISPOSABLE SPECULA

K-Number: K891589 · 1989-04-18

ApplicantSemantodontics, Inc.
Decision Date1989-04-18
Product CodeFXG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3MM DISPOSABLE SPECULA is the device name listed in this FDA 510(k) record. The listed applicant is Semantodontics, Inc.. It received FDA 510(k) clearance on 1989-04-18 under 510(k) number K891589. The device is classified under product code FXG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3MM DISPOSABLE SPECULA?

3MM DISPOSABLE SPECULA is a medical device that received FDA 510(k) clearance on 1989-04-18. The listed applicant is Semantodontics, Inc.. The 510(k) number is K891589.

When did 3MM DISPOSABLE SPECULA receive FDA 510(k) clearance?

3MM DISPOSABLE SPECULA received FDA 510(k) clearance on 1989-04-18, under 510(k) number K891589.

Who is the listed applicant for 3MM DISPOSABLE SPECULA?

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

What is the FDA product code for 3MM DISPOSABLE SPECULA?

The FDA product code for 3MM DISPOSABLE SPECULA is FXG.

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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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