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510(k) K854003

Device
STERILE SOFT TISSUE BIOPSY NEEDLE
Applicant
CO-MEDICAL, INC.
510(k) number
K854003
Product code
GEE  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-18
Date received
1985-09-30
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#

Contact
GARY BRUNNER
Address
2240 Lee St. Lakewood CO US 80215 80215

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
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
K792316TROTEX II SCREW NEEDLE BIOPSY INSTR. SETUrsus Konsult AB1979-12-18

Legacy Summary#

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FDA Review#

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