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510(k) K964825

FREEDOM TRAVELLER by Impact Case Technologies, Inc. — Product Code MLW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 19, 1997
Date Received: December 2, 1996
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Warmer, Peritoneal Dialysate
Device Class: Class II
Regulation Number: 876.5630
Review Panel: GU
Submission Type