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510(k) K841154

Device
PLAYTEX SLENDER REGULAR TAMPONS
Applicant
PLAYTEX, INC.
510(k) number
K841154
Product code
HIL  
Decision
Se - Postmarket Surveillance Required (SESP)
Decision date
1984-03-19
Date received
1984-03-19
Regulation
884.5460
Classification name
Tampon, Menstrual, Scented, Deodorized
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HIL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132208ONTEX AND OTHERS PROPRIETARY NAMESOntex Bvba2014-04-10
K132819PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONSPlaytex Manufacturing, Inc.2013-10-09
K120245PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONSPlaytex, Inc.2012-06-21
K111684PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELDPlaytex Manufacturing, Inc.2012-02-03
K081555TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTEDProcter & Gamble Co.2008-06-27
K073662PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONSPlaytex Products, Inc.2008-01-17
K072376PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONSPlaytex Products, Inc.2007-12-12
K070745MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONSPlaytex Products, Inc.2007-04-13
K060981PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONSPlaytex Products, Inc.2006-05-09
K051446FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONSFirst Quality Hygienic, Inc.2005-07-14
K050067FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSFirst Quality Hygienic, Inc.2005-02-01
K042773ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONSRostam , Ltd.2004-11-23
K040312TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUSProcter & Gamble Co.2004-05-03
K032173FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSFirst Quality Hygienic, Inc.2003-09-03
K032080ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONSRostam , Ltd.2003-08-14

Legacy Summary#

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FDA Review#

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