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510(k) K792316

Device
TROTEX II SCREW NEEDLE BIOPSY INSTR. SET
Applicant
URSUS KONSULT AB
510(k) number
K792316
Product code
GEE  
Decision
Substantially Equivalent (SESE)
Decision date
1979-12-18
Date received
1979-11-16
Regulation
878.4800
Classification name
Brush, Biopsy, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GEE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K854003STERILE SOFT TISSUE BIOPSY NEEDLECo-Medical, Inc.1985-10-18
K841008BIOPSY PUNCH, VARIOUSPremier Dental Products Co.1984-06-08
K822490DEFLECTING CYTOLOGY BRUSHVan-Tec, Inc.1982-09-14
K820259STERILE CYTOLOGY BRUSHESAmerican Endoscopy, Inc.1982-03-05
K812694WHISK-RMedi-Spec1981-10-26
K801304CAMLOC SYRINGE BIOPSY KITJohannah Medical Services, Inc.1980-06-17

Legacy Summary#

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FDA Review#

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