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510(k) K011941

Device
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
Applicant
THE KENDALL COMPANY
510(k) number
K011941
Product code
EFQ  
Decision
Substantially Equivalent (SESE)
Decision date
2001-08-22
Date received
2001-06-21
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL SPEARS
Address
15 Hampshire St. Mansfield MA US 02048 02048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.1999-06-11
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

Legacy Summary#

summary

FDA Review#

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