FDA.reportPublic FDA data

510(k) K962953

Device
DEODORANT PANTY SHIELD
Applicant
PARAGON TRADE BRANDS, INC.
510(k) number
K962953
Product code
HHL  
Decision
Substantially Equivalent (SESE)
Decision date
1996-10-10
Date received
1996-07-30
Regulation
884.5425
Classification name
Pad, Menstrual, Scented
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TONY SILWANOWICZ
Address
10 Commerce Dr. Gaffney SC US 29340 29340

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HHL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962962DEODORANT PANTY LINERParagon Trade Brands, Inc.1996-10-10
K962954DEODORANT MAXI PADParagon Trade Brands, Inc.1996-10-10
K961119CAREFREE PANTYLINERSPersonal Products Co.1996-04-17
K913238ALWAYS, UNSCENTED MENSTRUAL PADProcter & Gamble Co.1991-09-23
K913237ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PADProcter & Gamble Co.1991-09-23
K891473TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIOTambrands, Inc.1989-06-07
K890655NEW FREEDOM THIN DEODORANT MAXI PADSKimberly-Clark Corp.1989-05-01
K884951TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANTTambrands, Inc.1989-01-10
K884446MAXITHINS SUPER PADS, DEODORANTTambrands, Inc.1988-12-20
K884445MAXITHINS PANTY SHIELDS, DEODORANTTambrands, Inc.1988-12-05
K884444MAXITHINS REGULAR PADS, DEODORANTTambrands, Inc.1988-12-05
K884429ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PADProcter & Gamble Co.1988-12-02
K882094GARDS DEODORANT SANITARY NAPKINHospital Specialty Co.1988-09-22
K870066KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADSCascades Psh, Inc.1987-06-19
K864673UNSCENTED MENSTRUAL PADProcter & Gamble Mfg. Co.1987-01-21

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases