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FDA 510(k)

VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)

K-Number: K964555 · 1997-03-31

ApplicantVitrotec, Inc.
Decision Date1997-03-31
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) is the device name listed in this FDA 510(k) record. The listed applicant is Vitrotec, Inc.. It received FDA 510(k) clearance on 1997-03-31 under 510(k) number K964555. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)?

VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) is a medical device that received FDA 510(k) clearance on 1997-03-31. The listed applicant is Vitrotec, Inc.. The 510(k) number is K964555.

When did VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) receive FDA 510(k) clearance?

VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) received FDA 510(k) clearance on 1997-03-31, under 510(k) number K964555.

Who is the listed applicant for VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)?

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

What is the FDA product code for VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)?

The FDA product code for VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) is MPA.

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Related Devices (Code: MPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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