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FDA 510(k)

MEDCOMP ASH SPLIT

K-Number: K011576 · 2001-06-21

ApplicantMedical Components, Inc.
Decision Date2001-06-21
Product CodeNFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDCOMP ASH SPLIT 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 2001-06-21 under 510(k) number K011576. The device is classified under product code NFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDCOMP ASH SPLIT?

MEDCOMP ASH SPLIT is a medical device that received FDA 510(k) clearance on 2001-06-21. The listed applicant is Medical Components, Inc.. The 510(k) number is K011576.

When did MEDCOMP ASH SPLIT receive FDA 510(k) clearance?

MEDCOMP ASH SPLIT received FDA 510(k) clearance on 2001-06-21, under 510(k) number K011576.

Who is the listed applicant for MEDCOMP ASH SPLIT?

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 ASH SPLIT?

The FDA product code for MEDCOMP ASH SPLIT is NFK.

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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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