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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Irrigation Solution
510(k) Number K080609
Device Name SWC/DWC WARMING CABINETS
Applicant
Mac Medical
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Mac Medical
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number890.5950
Classification Product Code
LHC  
Date Received03/03/2008
Decision Date 06/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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