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510(k) K980395

Device
GLADRAGS COTTON MENSTRUAL PAD
Applicant
KEEPERS!, INC.
510(k) number
K980395
Product code
HHD  
Decision
Substantially Equivalent (SESE)
Decision date
1998-04-16
Date received
1998-02-02
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
BRENDA MALLORY
Address
2110 N. Williams P O Box 12648 Portland OR US 97212 97212

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
K953470FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)Mediquip, Inc.1995-11-21
K953633UNSCENTED MENSTRUAL PADTendasoft, Inc.1995-11-01
K953667UNSCENTED CURVED ULTRATHIN MAXI PADSParagon Trade Brands, Inc.1995-11-01
K953668UNSCENTED ULTRATHIN MAXI PADParagon Trade Brands, Inc.1995-11-01
K953553UNSCENTED MENSTRAL PADParagon Trade Brands, Inc.1995-10-27
K953517UNSCENTED MENSTRUAL PADParagon Trade Brands, Inc.1995-10-26
K953666UNSCENTED MENSTRAL PAD WITH WINGSParagon Trade Brands, Inc.1995-09-27
K953700UNSCENTED CURVED MAXI PADParagon Trade Brands, Inc.1995-09-27
K953487UNSCENTED MENSTRUAL SHIELDParagon Trade Brands, Inc.1995-08-09
K953488UNSCENTED MENSTRUAL LINERParagon 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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