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FDA 510(k)

HENKE DISPOSABLE SYRINGE

K-Number: K821537 · 1982-05-28

ApplicantC. B. Dumont Company, Inc.
Decision Date1982-05-28
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HENKE DISPOSABLE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is C. B. Dumont Company, Inc.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821537. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HENKE DISPOSABLE SYRINGE?

HENKE DISPOSABLE SYRINGE is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is C. B. Dumont Company, Inc.. The 510(k) number is K821537.

When did HENKE DISPOSABLE SYRINGE receive FDA 510(k) clearance?

HENKE DISPOSABLE SYRINGE received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821537.

Who is the listed applicant for HENKE DISPOSABLE SYRINGE?

The FDA 510(k) record lists C. B. Dumont Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HENKE DISPOSABLE SYRINGE?

The FDA product code for HENKE DISPOSABLE SYRINGE is FMF.

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Other records listing C. B. Dumont Company, 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.

K854804MULTIPLE I.V. SETS

Related Devices (Code: FMF)

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

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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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