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FDA 510(k)

CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET

K-Number: K980123 · 1998-03-09

ApplicantLouisville Laboratories, Inc.
Decision Date1998-03-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Louisville Laboratories, Inc.. It received FDA 510(k) clearance on 1998-03-09 under 510(k) number K980123. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET?

CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET is a medical device that received FDA 510(k) clearance on 1998-03-09. The listed applicant is Louisville Laboratories, Inc.. The 510(k) number is K980123.

When did CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET receive FDA 510(k) clearance?

CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET received FDA 510(k) clearance on 1998-03-09, under 510(k) number K980123.

Who is the listed applicant for CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET?

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

What is the FDA product code for CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET?

The FDA product code for CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET is GCJ.

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Related Devices (Code: GCJ)

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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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