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510(k) K904233

Device
CONVATEC ABSORBENT BANDAGE
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
510(k) number
K904233
Product code
EXE  
Decision
Substantially Equivalent (SESE)
Decision date
1991-03-06
Date received
1990-09-05
Regulation
876.5900
Classification name
Protector, Ostomy
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARILYN DREYLING
Address
P.O. Box 4000 Princeton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EXE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K770982UNITED SKIN BARRIERHowmedica Corp.1977-07-15
K760927STOMA SHIELD ADAPTERRudolfo T. Sanchez1977-01-26

Legacy Summary#

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FDA Review#

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