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FDA 510(k)

KANESON/COMFORT PLUS MANUAL BREAST PUMP

K-Number: K813247 · 1981-12-03

ApplicantMarshall Electronics, Inc.
Decision Date1981-12-03
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KANESON/COMFORT PLUS MANUAL BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Marshall Electronics, Inc.. It received FDA 510(k) clearance on 1981-12-03 under 510(k) number K813247. The device is classified under product code HGY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KANESON/COMFORT PLUS MANUAL BREAST PUMP?

KANESON/COMFORT PLUS MANUAL BREAST PUMP is a medical device that received FDA 510(k) clearance on 1981-12-03. The listed applicant is Marshall Electronics, Inc.. The 510(k) number is K813247.

When did KANESON/COMFORT PLUS MANUAL BREAST PUMP receive FDA 510(k) clearance?

KANESON/COMFORT PLUS MANUAL BREAST PUMP received FDA 510(k) clearance on 1981-12-03, under 510(k) number K813247.

Who is the listed applicant for KANESON/COMFORT PLUS MANUAL BREAST PUMP?

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

What is the FDA product code for KANESON/COMFORT PLUS MANUAL BREAST PUMP?

The FDA product code for KANESON/COMFORT PLUS MANUAL BREAST PUMP is HGY.

Related Clinical Trials

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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Other records listing Marshall Electronics, 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.

K790411AUTO TRAUMA KITK780023BLACK BAG, ELECTRONIC

Related Devices (Code: HGY)

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.

K101538HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)Philips Electronics UK LimitedK032845EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187The First Years, Inc.K013226EVENFLO COMFORT EASE MANUAL BREAST PUMP KITEvenflo Company, Inc.K011519AMEDA HYGIENIKITHollister, Inc.K971231WHITE RIVER MINI MANUAL BREAST PUMPWhite River ConceptsK962828EVERT-ITGenesis Industries, 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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