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510(k) K896750

LOFRIC(R), LOFRIC(R) CATH-KIT by Astra Meditec AB — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1990
Date Received
November 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Astra Meditec AB

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  • K882578 — ASTRA DENTAL IMPLANT SYSTEM (August 12, 1988)

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