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510(k) K803100

Device
STOMAHESIVE PASTE PROTECTIVE SKIN BARR
Applicant
E. R. SQUIBB & SONS, INC.
510(k) number
K803100
Product code
EZR  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-08
Date received
1980-12-09
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
40 W 57th St. New York NY US 10019 10019

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
K791146COLO-TAPESuburban Ostomy Supply Co., Inc.1979-07-30
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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