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FDA 510(k)

TSS/FIK

K-Number: K842501 · 1985-03-12

ApplicantZarcon Corp.
Decision Date1985-03-12
Product Code
DecisionSubstantially Equivalent

Device Summary

TSS/FIK is the device name listed in this FDA 510(k) record. The listed applicant is Zarcon Corp.. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K842501. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSS/FIK?

TSS/FIK is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Zarcon Corp.. The 510(k) number is K842501.

When did TSS/FIK receive FDA 510(k) clearance?

TSS/FIK received FDA 510(k) clearance on 1985-03-12, under 510(k) number K842501.

Who is the listed applicant for TSS/FIK?

The FDA 510(k) record lists Zarcon Corp. 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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