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FDA 510(k)

BARD HYSTERO-FLO II PUMP

K-Number: K933384 · 1994-12-30

ApplicantDavol Inc., Sub. C. R. Bard, Inc.
Decision Date1994-12-30
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BARD HYSTERO-FLO II PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. It received FDA 510(k) clearance on 1994-12-30 under 510(k) number K933384. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD HYSTERO-FLO II PUMP?

BARD HYSTERO-FLO II PUMP is a medical device that received FDA 510(k) clearance on 1994-12-30. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K933384.

When did BARD HYSTERO-FLO II PUMP receive FDA 510(k) clearance?

BARD HYSTERO-FLO II PUMP received FDA 510(k) clearance on 1994-12-30, under 510(k) number K933384.

Who is the listed applicant for BARD HYSTERO-FLO II PUMP?

The FDA 510(k) record lists Davol Inc., Sub. C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD HYSTERO-FLO II PUMP?

The FDA product code for BARD HYSTERO-FLO II PUMP is HIG.

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Other records listing Davol Inc., Sub. C. R. Bard, Inc. as applicant

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Related Devices (Code: HIG)

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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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