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FDA 510(k) Application Details - K101355
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K101355
Device Name
Sleeve, Limb, Compressible
Applicant
AUGDVT LLC
1468 HARWELL AVE
CROFTON, MD 21114 US
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Contact
E. J. SMITH
Other 510(k) Applications for this Contact
Regulation Number
870.5800
More FDA Info for this Regulation Number
Classification Product Code
JOW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/2010
Decision Date
10/26/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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