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510(k) K760815

Device
FITTING/DIALYZER
Applicant
COBE LABORATORIES, INC.
510(k) number
K760815
Product code
FTG  
Decision
Substantially Equivalent (SESE)
Decision date
1976-11-19
Date received
1976-10-12
Regulation
878.4580
Classification name
Illuminator, Remote
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
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 FTG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K801065NIKKISO PARALLEL FLOW DIALYZERSInt'L Marketing & Sales Corp.1980-08-07

Legacy Summary#

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FDA Review#

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