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510(k) K780409

COLOPLAST-DURASEAL OSTOMY APPLIANCE by C.R. Bard, Inc. — Product Code EZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1978
Date Received
March 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Colostomy, Disposable
Device Class
Class I
Regulation Number
876.5900
Review Panel
GU
Submission Type

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