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FDA 510(k)

PLASIATEK ACTUATOR

K-Number: K041917 · 2005-01-07

ApplicantPlasiatek, LLC
Decision Date2005-01-07
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PLASIATEK ACTUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Plasiatek, LLC. It received FDA 510(k) clearance on 2005-01-07 under 510(k) number K041917. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASIATEK ACTUATOR?

PLASIATEK ACTUATOR is a medical device that received FDA 510(k) clearance on 2005-01-07. The listed applicant is Plasiatek, LLC. The 510(k) number is K041917.

When did PLASIATEK ACTUATOR receive FDA 510(k) clearance?

PLASIATEK ACTUATOR received FDA 510(k) clearance on 2005-01-07, under 510(k) number K041917.

Who is the listed applicant for PLASIATEK ACTUATOR?

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

What is the FDA product code for PLASIATEK ACTUATOR?

The FDA product code for PLASIATEK ACTUATOR is BTR.

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Official Source

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