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FDA 510(k)

MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S

K-Number: K010021 · 2001-02-23

ApplicantMedical Components, Inc.
Decision Date2001-02-23
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 2001-02-23 under 510(k) number K010021. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S?

MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S is a medical device that received FDA 510(k) clearance on 2001-02-23. The listed applicant is Medical Components, Inc.. The 510(k) number is K010021.

When did MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S receive FDA 510(k) clearance?

MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S received FDA 510(k) clearance on 2001-02-23, under 510(k) number K010021.

Who is the listed applicant for MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S?

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

What is the FDA product code for MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S?

The FDA product code for MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S is FOZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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