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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
510(k) Number K101614
Device Name HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809
Applicant
Dm Systems, Incorporated
1105 Buchbrush Dr.
Folsm,  CA  95630
Applicant Contact MICHAEL ZMUDA
Correspondent
Dm Systems, Incorporated
1105 Buchbrush Dr.
Folsm,  CA  95630
Correspondent Contact MICHAEL ZMUDA
Regulation Number880.5780
Classification Product Code
DWL  
Date Received06/09/2010
Decision Date 01/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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