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FDA 510(k)

DOUBLE UP BREAST PUMP

K-Number: K964396 · 1997-06-06

ApplicantThe Natural Choice Co., Inc.
Decision Date1997-06-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DOUBLE UP BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is The Natural Choice Co., Inc.. It received FDA 510(k) clearance on 1997-06-06 under 510(k) number K964396. 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 DOUBLE UP BREAST PUMP?

DOUBLE UP BREAST PUMP is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is The Natural Choice Co., Inc.. The 510(k) number is K964396.

When did DOUBLE UP BREAST PUMP receive FDA 510(k) clearance?

DOUBLE UP BREAST PUMP received FDA 510(k) clearance on 1997-06-06, under 510(k) number K964396.

Who is the listed applicant for DOUBLE UP BREAST PUMP?

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

What is the FDA product code for DOUBLE UP BREAST PUMP?

The FDA product code for DOUBLE UP BREAST PUMP is HGX.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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