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510(k) K953517

Device
UNSCENTED MENSTRUAL PAD
Applicant
PARAGON TRADE BRANDS, INC.
510(k) number
K953517
Product code
HHD  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-26
Date received
1995-07-27
Regulation
884.5435
Classification name
Pad, Menstrual, Unscented
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TONY SILWANOWICZ
Address
33325 8th Ave. S. Federal Way WA US 98003 98003

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HHD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071827ALWAYS MENSTRUAL PADSProcter & Gamble, Inc.2007-09-20
K012629ALWAYS DUETSProcter & Gamble Co.2001-10-05
K003843ENVIVE MINIFORMSProcter & Gamble Co.2001-02-08
K993870UNSCENTED INTERLABIAL MENSTRUAL PADProcter & Gamble Co.2000-01-18
K980395GLADRAGS COTTON MENSTRUAL PADKeepers!, Inc.1998-04-16
K953470FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)Mediquip, Inc.1995-11-21
K953668UNSCENTED ULTRATHIN MAXI PADParagon Trade Brands, Inc.1995-11-01
K953667UNSCENTED CURVED ULTRATHIN MAXI PADSParagon Trade Brands, Inc.1995-11-01
K953633UNSCENTED MENSTRUAL PADTendasoft, Inc.1995-11-01
K953553UNSCENTED MENSTRAL PADParagon Trade Brands, Inc.1995-10-27
K953700UNSCENTED CURVED MAXI PADParagon Trade Brands, Inc.1995-09-27
K953666UNSCENTED MENSTRAL PAD WITH WINGSParagon Trade Brands, Inc.1995-09-27
K953488UNSCENTED MENSTRUAL LINERParagon Trade Brands, Inc.1995-08-09
K953487UNSCENTED MENSTRUAL SHIELDParagon Trade Brands, Inc.1995-08-09
K951693CARESS SANITARY NAPKINSterling U.S.A., Inc.1995-07-25

Legacy Summary#

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FDA Review#

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