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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K101355
Device Name AUGEASE VASCULAR AUGMENTATION DEVICE
Applicant
AUGDVT LLC
1468 HARWELL AVE
CROFTON,  MD  21114
Applicant Contact E. J. SMITH
Correspondent
AUGDVT LLC
1468 HARWELL AVE
CROFTON,  MD  21114
Correspondent Contact E. J. SMITH
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/14/2010
Decision Date 10/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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