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510(k) K800213

Device
PHARMACY ADDITIVE SYRINGE SET
Applicant
CUTTER LABORATORIES, INC.
510(k) number
K800213
Product code
KYW  
Decision
Substantially Equivalent (SESE)
Decision date
1980-02-26
Date received
1980-02-01
Regulation
880.6430
Classification name
Container, Liquid Medication, Graduated
Medical specialty
General Hospital
Review panel
General Hospital
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 KYW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K791345MEDICINE CUPGeneral Clinical Plastics Corp.1979-08-03

Legacy Summary#

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FDA Review#

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