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FDA 510(k)

BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA

K-Number: K921722 · 1994-05-02

ApplicantBard Reproductive Systems
Decision Date1994-05-02
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Bard Reproductive Systems. It received FDA 510(k) clearance on 1994-05-02 under 510(k) number K921722. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA?

BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA is a medical device that received FDA 510(k) clearance on 1994-05-02. The listed applicant is Bard Reproductive Systems. The 510(k) number is K921722.

When did BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA receive FDA 510(k) clearance?

BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA received FDA 510(k) clearance on 1994-05-02, under 510(k) number K921722.

Who is the listed applicant for BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA?

The FDA 510(k) record lists Bard Reproductive Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA?

The FDA product code for BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA is HET.

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Official Source

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

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