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FDA 510(k)

MEDELA BREAST-PUMP LACTINA

K-Number: K875300 · 1988-04-06

ApplicantMedela, Inc.
Decision Date1988-04-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDELA BREAST-PUMP LACTINA is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 1988-04-06 under 510(k) number K875300. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDELA BREAST-PUMP LACTINA?

MEDELA BREAST-PUMP LACTINA is a medical device that received FDA 510(k) clearance on 1988-04-06. The listed applicant is Medela, Inc.. The 510(k) number is K875300.

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

MEDELA BREAST-PUMP LACTINA received FDA 510(k) clearance on 1988-04-06, under 510(k) number K875300.

Who is the listed applicant for MEDELA BREAST-PUMP LACTINA?

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 BREAST-PUMP LACTINA?

The FDA product code for MEDELA BREAST-PUMP LACTINA is HGX.

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Other records listing Medela, Inc. as applicant

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Related Devices (Code: HGX)

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.

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

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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