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510(k) K880327

MARLEN ULTRA ILEOSTOMY POUCH-5000 by Marlen Mfg. & Development Co. — Product Code EZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1988
Date Received
January 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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