PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS— 510(k) K132819

Name: FDA 510(k) clearance K132819
Creator: U.S. Food and Drug Administration
Published: 2013-10-09

Substantially Equivalent

Playtex Manufacturing, Inc.

FDA 510(k) clearance K132819 for PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS, Substantially Equivalent on 2013-10-09. Applicant: Playtex Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant: Playtex Manufacturing, Inc.
Product code: Code HIL
Device class: Class 2
Regulation: 21 CFR 884.5460
Advisory panel: Obstetrics/Gynecology
Date received: 2013-09-09
Decision date: 2013-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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