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510(k) K925790

EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S by Deroyal Industries, Inc. — Product Code EYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1993
Date Received
November 16, 1992
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

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