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510(k) K913643

Device
MUCOUS SPECIMEN TRAP
Applicant
MEDICAL DEVICE INSPECTION CO., INC.
510(k) number
K913643
Product code
BYZ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-10
Date received
1991-08-14
Regulation
880.6740
Classification name
Trap, Sterile Specimen
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KOTULA COOK
Address
55 Northern Blvd., Suite 301 Great Neck NY US 11021 11021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925412ELECTROMEDICS TISSUE TRAP/ #TT280Electromedics, Inc.1993-02-05
K902883TISSUE/POLYP TRAP SYSTEMTriton Technology, Inc.1990-09-12
K841409BUSH NECK W/PLUGWarne Surgical Products, Ltd.1984-04-18
K840253ONE-WAY AIR VALVEDelta Medical Industries1984-04-05
K834467SPECIMEN TRAPMicrovasive1984-02-17
K822556CRITICAL MEASUREMENT UNITBemis Health Care1982-10-18
K822557SPECIMEN ADAPTORBemis Health Care1982-10-18
K791847ASPRI-LUKEMedical Marketing Group1979-10-02

Legacy Summary#

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FDA Review#

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