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FDA 510(k)

PLAYTEX EMBRACE PETITE BREAST PUMP

K-Number: K061013 · 2006-08-15

ApplicantPlaytex Products, Inc.
Decision Date2006-08-15
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PLAYTEX EMBRACE PETITE BREAST PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Playtex Products, Inc.. It received FDA 510(k) clearance on 2006-08-15 under 510(k) number K061013. 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 PLAYTEX EMBRACE PETITE BREAST PUMP?

PLAYTEX EMBRACE PETITE BREAST PUMP is a medical device that received FDA 510(k) clearance on 2006-08-15. The listed applicant is Playtex Products, Inc.. The 510(k) number is K061013.

When did PLAYTEX EMBRACE PETITE BREAST PUMP receive FDA 510(k) clearance?

PLAYTEX EMBRACE PETITE BREAST PUMP received FDA 510(k) clearance on 2006-08-15, under 510(k) number K061013.

Who is the listed applicant for PLAYTEX EMBRACE PETITE BREAST PUMP?

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

What is the FDA product code for PLAYTEX EMBRACE PETITE BREAST PUMP?

The FDA product code for PLAYTEX EMBRACE PETITE BREAST PUMP is HGX.

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Other records listing Playtex Products, 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.

K073662PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONSK072376PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONSK070745MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONSK060981PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONSK032636PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)K022594PLAYTEX BREAST PUMP

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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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