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510(k) K893522

Device
SURGEON'S GLOVES
Applicant
THAI FUJI LATEX CO., LTD.
510(k) number
K893522
Product code
FGO  
Decision
Substantially Equivalent (SESE)
Decision date
1990-01-22
Date received
1989-05-08
Regulation
876.4680
Classification name
Dislodger, Stone, Flexible
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROGER J FLEISCHMANN
Address
650 California St. Suite 2550 San Francisco CA US 94108 94108

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FGO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001563SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SETScion Cardiovascular, Inc.2000-11-22
K970121STONE DISLODGER, BASKETBoston Scientific Corp1997-04-02
K963750RETRIEVAL SNAREBoston Scientific Corp1996-11-22
K962676DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.1996-10-04
K951309STONE DISLODGER, BASKETBoston Scientific Corp1995-05-17
K933261GRASPING FORCEPSSurgitek1994-01-11
K934598GRASPING FORCEPS OR RETRIEVAL FORCEPSAnnex Medical, Inc.1994-01-07
K921295INTRAVENOUS CATHETERS MODIFICATIONSCritikon Company, LLC1993-05-17
K922542GRASPING FORCEPSSurgitek1992-08-19
K914111METAL URETERAL BASKET STONE DISLODGER, HELICALAnnex Medical, Inc.1992-02-28
K914112METAL URETERAL BASKET STONE DISLODGER, FLAT WIREAnnex Medical, Inc.1992-02-28
K914110GRASPING FORCEPSAnnex Medical, Inc.1992-02-28
K896322CN GAURD, STERILE LATEX SURGICAL GLOVESC.N. Technocrats1990-07-12
K895080SURGICAL GLOVESJet Far Industries, Inc.1990-01-24
K885168RUBENSTEIN URETERAL STONE FRAGMENT BRUSHBoston Scientific Corp1989-09-08

Legacy Summary#

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FDA Review#

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