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FDA 510(k)

PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS

K-Number: K132819 · 2013-10-09

ApplicantPlaytex Manufacturing, Inc.
Decision Date2013-10-09
Product CodeHIL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS is the device name listed in this FDA 510(k) record. The listed applicant is Playtex Manufacturing, Inc.. It received FDA 510(k) clearance on 2013-10-09 under 510(k) number K132819. The device is classified under product code HIL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS?

PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS is a medical device that received FDA 510(k) clearance on 2013-10-09. The listed applicant is Playtex Manufacturing, Inc.. The 510(k) number is K132819.

When did PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS receive FDA 510(k) clearance?

PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS received FDA 510(k) clearance on 2013-10-09, under 510(k) number K132819.

Who is the listed applicant for PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS?

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

What is the FDA product code for PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS?

The FDA product code for PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS is HIL.

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Other records listing Playtex Manufacturing, 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.

K180167Playtex Stella TamponsK111684PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

Related Devices (Code: HIL)

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.

K120245PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONSPlaytex, Inc.K111684PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELDPlaytex Manufacturing, Inc.K081555TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTEDProcter & Gamble Co.K073662PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONSPlaytex Products, Inc.K072376PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONSPlaytex Products, Inc.K070745MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONSPlaytex Products, Inc.

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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