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510(k) K792633

Device
STERILIZATION PROCESS/OUTERWRAP
Applicant
PROCTER & GAMBLE MFG. CO.
510(k) number
K792633
Product code
KET  
Decision
Substantially Equivalent (SESE)
Decision date
1980-01-11
Date received
1979-12-19
Regulation
864.3010
Classification name
Filters, Cell Collection, Tissue Processing
Medical specialty
Pathology
Review panel
Pathology
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 KET  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K875122DISPOSABLE STERILE SYRINGE FILTERSCorning Medical & Scientific1988-01-12
K870196PCTE MICROPOROUS MEMBRANE FILTERPoretics Corp.1987-05-12
K844671CORNING DISPOSAL STERILE FILTER SYSTEM-NYLONCorning Medical & Scientific1985-02-25
K840556DISPOSABLE SYRINGE FILTERSCorning Medical & Scientific1984-03-05

Legacy Summary#

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FDA Review#

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