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FDA 510(k)

GROMMET STYLE VENTURI

K-Number: K904597 · 1991-01-28

ApplicantRiver Medical, Inc.
Decision Date1991-01-28
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GROMMET STYLE VENTURI is the device name listed in this FDA 510(k) record. The listed applicant is River Medical, Inc.. It received FDA 510(k) clearance on 1991-01-28 under 510(k) number K904597. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GROMMET STYLE VENTURI?

GROMMET STYLE VENTURI is a medical device that received FDA 510(k) clearance on 1991-01-28. The listed applicant is River Medical, Inc.. The 510(k) number is K904597.

When did GROMMET STYLE VENTURI receive FDA 510(k) clearance?

GROMMET STYLE VENTURI received FDA 510(k) clearance on 1991-01-28, under 510(k) number K904597.

Who is the listed applicant for GROMMET STYLE VENTURI?

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

What is the FDA product code for GROMMET STYLE VENTURI?

The FDA product code for GROMMET STYLE VENTURI is ETD.

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Other records listing River Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023174DISPOSABLE TEMPORARY PACING WIREK944351SMARTDOSE IV PREFILLED INFUSION CONTAINERK944352SMARTDOSE III INFUSION CONTAINERK945298SMARTFLOW I ADMINISTRATION SETK943692SMART DOSE(TM)K932895RIVER PUMP

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Related Devices (Code: ETD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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