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FDA 510(k)

MEDELA NAMUAL BREAST PUMP

K-Number: K823840 · 1983-01-24

ApplicantMedela, Inc.
Decision Date1983-01-24
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDELA NAMUAL BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 1983-01-24 under 510(k) number K823840. 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 MEDELA NAMUAL BREAST PUMP?

MEDELA NAMUAL BREAST PUMP is a medical device that received FDA 510(k) clearance on 1983-01-24. The listed applicant is Medela, Inc.. The 510(k) number is K823840.

When did MEDELA NAMUAL BREAST PUMP receive FDA 510(k) clearance?

MEDELA NAMUAL BREAST PUMP received FDA 510(k) clearance on 1983-01-24, under 510(k) number K823840.

Who is the listed applicant for MEDELA NAMUAL BREAST PUMP?

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

What is the FDA product code for MEDELA NAMUAL BREAST PUMP?

The FDA product code for MEDELA NAMUAL BREAST PUMP is HGY.

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Other records listing Medela, 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.

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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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