FDA 510(k)

E-Z-EM(R) LUFKIN BIOPSY NEEDLES

K-Number: K882601 · 1988-07-25

Decision Date1988-07-25

Product CodeGDM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

E-Z-EM(R) LUFKIN BIOPSY NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1988-07-25 under 510(k) number K882601. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Z-EM(R) LUFKIN BIOPSY NEEDLES?

E-Z-EM(R) LUFKIN BIOPSY NEEDLES is a medical device that received FDA 510(k) clearance on 1988-07-25. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K882601.

When did E-Z-EM(R) LUFKIN BIOPSY NEEDLES receive FDA 510(k) clearance?

E-Z-EM(R) LUFKIN BIOPSY NEEDLES received FDA 510(k) clearance on 1988-07-25, under 510(k) number K882601.

Who is the listed applicant for E-Z-EM(R) LUFKIN BIOPSY NEEDLES?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Z-EM(R) LUFKIN BIOPSY NEEDLES?

The FDA product code for E-Z-EM(R) LUFKIN BIOPSY NEEDLES is GDM.

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Other records listing E-Z-Em, Inc. as applicant

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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.