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FDA 510(k)

FUJIFILM Distal Cap Models 33-40

K-Number: K193123 · 2019-12-11

Decision Date2019-12-11
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Distal Cap Models 33-40 is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2019-12-11 under approval number K193123. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Distal Cap Models 33-40?

FUJIFILM Distal Cap Models 33-40 is a medical device that received FDA 510(k) clearance on 2019-12-11. It is manufactured by Fujifilm Corporation. The 510(k) number is K193123.

When was FUJIFILM Distal Cap Models 33-40 approved by the FDA?

FUJIFILM Distal Cap Models 33-40 received FDA 510(k) clearance on 2019-12-11, under approval number K193123.

What company makes FUJIFILM Distal Cap Models 33-40?

FUJIFILM Distal Cap Models 33-40 is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Distal Cap Models 33-40?

The FDA product code for FUJIFILM Distal Cap Models 33-40 is FDS.

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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.