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FDA 510(k)

LINEZOLID, 30UG, BBL SENSI-DISC

K-Number: K002165 · 2000-09-05

ApplicantDickinson, and Co.
Decision Date2000-09-05
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LINEZOLID, 30UG, BBL SENSI-DISC is the device name listed in this FDA 510(k) record. The listed applicant is Dickinson, and Co.. It received FDA 510(k) clearance on 2000-09-05 under 510(k) number K002165. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINEZOLID, 30UG, BBL SENSI-DISC?

LINEZOLID, 30UG, BBL SENSI-DISC is a medical device that received FDA 510(k) clearance on 2000-09-05. The listed applicant is Dickinson, and Co.. The 510(k) number is K002165.

When did LINEZOLID, 30UG, BBL SENSI-DISC receive FDA 510(k) clearance?

LINEZOLID, 30UG, BBL SENSI-DISC received FDA 510(k) clearance on 2000-09-05, under 510(k) number K002165.

Who is the listed applicant for LINEZOLID, 30UG, BBL SENSI-DISC?

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

What is the FDA product code for LINEZOLID, 30UG, BBL SENSI-DISC?

The FDA product code for LINEZOLID, 30UG, BBL SENSI-DISC is JTN.

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Official Source

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