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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, bone, vertebroplasty
510(k) Number K100404
Device Name ASCENDX VCF REDUCTION SYSTEM
Applicant
AOI MEDICAL, INC.
1835 MARKET STREET
29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
AOI MEDICAL, INC.
1835 MARKET STREET
29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3027
Classification Product Code
NDN  
Date Received02/16/2010
Decision Date 12/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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