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FDA 510(k)

EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT

K-Number: K013226 · 2001-12-20

ApplicantEvenflo Company, Inc.
Decision Date2001-12-20
Product CodeHGY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT is the device name listed in this FDA 510(k) record. The listed applicant is Evenflo Company, Inc.. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K013226. 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 EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT?

EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Evenflo Company, Inc.. The 510(k) number is K013226.

When did EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT receive FDA 510(k) clearance?

EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT received FDA 510(k) clearance on 2001-12-20, under 510(k) number K013226.

Who is the listed applicant for EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT?

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

What is the FDA product code for EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT?

The FDA product code for EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT is HGY.

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Other records listing Evenflo 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.

K102600SIMPLYGO BREAST PUMPK100435AMEDA PLATINUM BREAST PUMPK092770SIMPLYGO HANDS FREE BREAST PUMPK082307EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KITK053493BERRY FRUITY TEETHERK052909EVENFLO ELAN BREAST PUMP

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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.K011519AMEDA HYGIENIKITHollister, Inc.K971231WHITE RIVER MINI MANUAL BREAST PUMPWhite River ConceptsK962828EVERT-ITGenesis Industries, Inc.K952034MEDELA'S FOOT PUMPMedela, 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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