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510(k) K791146

Device
COLO-TAPE
Applicant
SUBURBAN OSTOMY SUPPLY CO., INC.
510(k) number
K791146
Product code
EZR  
Decision
Substantially Equivalent (SESE)
Decision date
1979-07-30
Date received
1979-06-18
Regulation
876.5900
Classification name
Cement, Stomal Appliance, Ostomy
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
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 EZR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K844341UNITED SKIN BARRIER PASTEHowmedica Corp.1985-01-18
K803100STOMAHESIVE PASTE PROTECTIVE SKIN BARRE. R. Squibb & Sons, Inc.1981-01-08
K761340OSTOMY KARAYA GUM POWDERHowmedica Corp.1977-03-07
K770230KARAYA GUM POWDERAtlantic Surgical1977-02-28
K761319KARAYA GUM PRODUCTS - PROCESS CHANGEHowmedica Corp.1977-02-15

Legacy Summary#

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FDA Review#

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