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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Peritoneal Dialysate
510(k) Number K964825
Device Name FREEDOM TRAVELLER
Applicant
Impact Case Technologies, Inc.
20 Steelcase Rd., W.,
Units 6 & 7
Markham, Ontario,  CA L3R 1B2
Applicant Contact ANGELA HAMLEN
Correspondent
Impact Case Technologies, Inc.
20 Steelcase Rd., W.,
Units 6 & 7
Markham, Ontario,  CA L3R 1B2
Correspondent Contact ANGELA HAMLEN
Regulation Number876.5630
Classification Product Code
MLW  
Date Received12/02/1996
Decision Date 05/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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