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FDA 510(k)

ENDCUP

K-Number: K945862 · 1995-02-23

ApplicantLewtek
Decision Date1995-02-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDCUP is the device name listed in this FDA 510(k) record. The listed applicant is Lewtek. It received FDA 510(k) clearance on 1995-02-23 under 510(k) number K945862. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDCUP?

ENDCUP is a medical device that received FDA 510(k) clearance on 1995-02-23. The listed applicant is Lewtek. The 510(k) number is K945862.

When did ENDCUP receive FDA 510(k) clearance?

ENDCUP received FDA 510(k) clearance on 1995-02-23, under 510(k) number K945862.

Who is the listed applicant for ENDCUP?

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

What is the FDA product code for ENDCUP?

The FDA product code for ENDCUP is GCJ.

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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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