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FDA 510(k) Application Details - K151112
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
More FDA Info for this Device
510(K) Number
K151112
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
ANGIOTECH
100 DENNIS DRIVE
READING, PA 19606 US
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Contact
HILARY WELLS
Other 510(k) Applications for this Contact
Regulation Number
878.5010
More FDA Info for this Regulation Number
Classification Product Code
GAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/28/2015
Decision Date
09/10/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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