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FDA 510(k)

X-BEAM FILM 3TC

K-Number: K833592 · 1983-12-27

ApplicantAmorient Ent.
Decision Date1983-12-27
Product Code
DecisionSubstantially Equivalent

Device Summary

X-BEAM FILM 3TC is the device name listed in this FDA 510(k) record. The listed applicant is Amorient Ent.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K833592. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-BEAM FILM 3TC?

X-BEAM FILM 3TC is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Amorient Ent.. The 510(k) number is K833592.

When did X-BEAM FILM 3TC receive FDA 510(k) clearance?

X-BEAM FILM 3TC received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833592.

Who is the listed applicant for X-BEAM FILM 3TC?

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

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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