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510(k) K890310

STERILE FOLEY CATHETER by Kosan Far East Ent. , Ltd. — Product Code EYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Upper Urinary Tract
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Kosan Far East Ent. , Ltd.

  • K890311 — KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE) (March 3, 1989)

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