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510(k) K830187

Device
FOCUS FLUID
Applicant
HEMATOLOGY MARKETING ASSOC.
510(k) number
K830187
Product code
EIF  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-01
Date received
1983-01-19
Regulation
872.4565
Classification name
Accessories, Retractor, Dental
Medical specialty
Dental
Review panel
Hematology
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 EIF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940785MOUTH PROPSWorldwide Dental, Inc.1994-10-05
K873960LEWIS SAFE SLEEVECheri Lewis, D.D.S.1987-12-04
K830116SULCARINGSNorth Pacific Dental, Inc.1983-02-18

Legacy Summary#

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FDA Review#

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