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FDA 510(k)

X-FORCE

K-Number: K111557 · 2011-11-10

ApplicantSeven Seas Distribtion and Manufacturing, LLC
Decision Date2011-11-10
Product CodeNYN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

X-FORCE is the device name listed in this FDA 510(k) record. The listed applicant is Seven Seas Distribtion and Manufacturing, LLC. It received FDA 510(k) clearance on 2011-11-10 under 510(k) number K111557. The device is classified under product code NYN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-FORCE?

X-FORCE is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Seven Seas Distribtion and Manufacturing, LLC. The 510(k) number is K111557.

When did X-FORCE receive FDA 510(k) clearance?

X-FORCE received FDA 510(k) clearance on 2011-11-10, under 510(k) number K111557.

Who is the listed applicant for X-FORCE?

The FDA 510(k) record lists Seven Seas Distribtion and Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-FORCE?

The FDA product code for X-FORCE is NYN.

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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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