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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Heating, Powered
510(k) Number K050524
Device Name EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000
Applicant
Marda Medical, Inc.
895 NE Dixie Hwy.
Suite 201
Jensen Beach,  FL  34957
Applicant Contact Howard Schrayer
Correspondent
Marda Medical, Inc.
895 NE Dixie Hwy.
Suite 201
Jensen Beach,  FL  34957
Correspondent Contact Howard Schrayer
Regulation Number890.5950
Classification Product Code
IRQ  
Date Received03/02/2005
Decision Date 09/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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