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FDA 510(k) Application Details - K133420
Device Classification Name
Suture, Surgical, Absorbable, Polydioxanone
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510(K) Number
K133420
Device Name
Suture, Surgical, Absorbable, Polydioxanone
Applicant
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
100 DENNIS DR.
READING, PA 19606 US
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Contact
KIRSTEN STOWELL
Other 510(k) Applications for this Contact
Regulation Number
878.4840
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Classification Product Code
NEW
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More FDA Info for this Product Code
Date Received
11/08/2013
Decision Date
11/29/2013
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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