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FDA 510(k)

AXIPUMP MANUAL BREAST PUMP

K-Number: K823461 · 1983-01-18

ApplicantD.J. Colgate Medical, Ltd.
Decision Date1983-01-18
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AXIPUMP MANUAL BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is D.J. Colgate Medical, Ltd.. It received FDA 510(k) clearance on 1983-01-18 under 510(k) number K823461. 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 AXIPUMP MANUAL BREAST PUMP?

AXIPUMP MANUAL BREAST PUMP is a medical device that received FDA 510(k) clearance on 1983-01-18. The listed applicant is D.J. Colgate Medical, Ltd.. The 510(k) number is K823461.

When did AXIPUMP MANUAL BREAST PUMP receive FDA 510(k) clearance?

AXIPUMP MANUAL BREAST PUMP received FDA 510(k) clearance on 1983-01-18, under 510(k) number K823461.

Who is the listed applicant for AXIPUMP MANUAL BREAST PUMP?

The FDA 510(k) record lists D.J. Colgate Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIPUMP MANUAL BREAST PUMP?

The FDA product code for AXIPUMP MANUAL BREAST PUMP is HGY.

Related Clinical Trials

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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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