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510(k) K770408

KARAYA GUM POWDER, OSTOMY by Howmedica Corp. — Product Code EZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1977
Date Received
March 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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