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510(k) K991215

Device
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
Applicant
SYMTEX HEALTHCARE CORP.
510(k) number
K991215
Product code
EFQ  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-11
Date received
1999-04-09
Regulation
510(k) Premarket Notification
Classification name
Gauze/sponge, Internal
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD S WANG
Address
783 Pinefalls Ave. Walnut CA US 91789 91789

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EFQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong Industries1999-08-12
K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.1999-06-09
K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical Industries1999-04-23
K984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.1999-02-18
K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.1999-02-12
K983348DYNAREX TRACHEOSTOMY SPONGEDynarex Corp.1998-12-11
K983450STARRYSHINE GAUZE SPONGET.C. Dental Products, Inc.1998-11-12
K982648JOAN IICelanese Acetate Co.1998-09-30
K980791DUMEX PAK-ITS WOVEN RIBBON PACKINGDumex Medical Surgical Products, Ltd.1998-04-29
K974316HYDROFERA FEMORAL WICKHydrofera, LLC1998-02-13
K974347BALDUR NON-STERILE COTTON SPONGESBaldur Systems Corp.1998-02-10
K973763KENDALL CURITY IODOFORM PACKING STRIPKendall Healthcare Products Co. Div.Of Tyco Health1997-12-31
K973580INVOTEC CLEAN PADInvotec International, Inc.1997-12-10
K973299PIN CARE KITBrown Medical Industries1997-11-26
K971088OPPORTUNITY INCISION AND DRAINAGE TRAYOpportunity, Inc.1997-09-16

Legacy Summary#

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FDA Review#

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