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FDA 510(k)

WELLINGTON HOSPITAL PATTERN SELF-RETAIN

K-Number: K843388 · 1984-10-01

ApplicantDowns Surgical , Ltd.
Decision Date1984-10-01
Product CodeHDF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WELLINGTON HOSPITAL PATTERN SELF-RETAIN is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1984-10-01 under 510(k) number K843388. The device is classified under product code HDF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELLINGTON HOSPITAL PATTERN SELF-RETAIN?

WELLINGTON HOSPITAL PATTERN SELF-RETAIN is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K843388.

When did WELLINGTON HOSPITAL PATTERN SELF-RETAIN receive FDA 510(k) clearance?

WELLINGTON HOSPITAL PATTERN SELF-RETAIN received FDA 510(k) clearance on 1984-10-01, under 510(k) number K843388.

Who is the listed applicant for WELLINGTON HOSPITAL PATTERN SELF-RETAIN?

The FDA 510(k) record lists Downs Surgical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLINGTON HOSPITAL PATTERN SELF-RETAIN?

The FDA product code for WELLINGTON HOSPITAL PATTERN SELF-RETAIN is HDF.

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Related Devices (Code: HDF)

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.

K926429VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTThomasville Medical Assoc.K902019MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPSGynescope Corp.K891041MIYA SPECULUMZinnanti Surgical Instruments, Inc.K891044LASER SPECULAZinnanti Surgical Instruments, Inc.K890375VAGINAL SPECULUMKinetic Medical ProductsK862478HAYES VAGINAL SHIELDFranklin Medical USA, Inc.

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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