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510(k) K820237

COBE ACUFLEX FSN, #15-208 by Cobe Laboratories, Inc. — Product Code LFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1982
Date Received
January 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Femoral
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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