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FDA 510(k)

TWIXEL(TM)

K-Number: K885056 · 1989-01-04

ApplicantFouts Development, Inc.
Decision Date1989-01-04
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TWIXEL(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Fouts Development, Inc.. It received FDA 510(k) clearance on 1989-01-04 under 510(k) number K885056. The device is classified under product code JES. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWIXEL(TM)?

TWIXEL(TM) is a medical device that received FDA 510(k) clearance on 1989-01-04. The listed applicant is Fouts Development, Inc.. The 510(k) number is K885056.

When did TWIXEL(TM) receive FDA 510(k) clearance?

TWIXEL(TM) received FDA 510(k) clearance on 1989-01-04, under 510(k) number K885056.

Who is the listed applicant for TWIXEL(TM)?

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

What is the FDA product code for TWIXEL(TM)?

The FDA product code for TWIXEL(TM) is JES.

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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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