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FDA 510(k) Application Details - K140039
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
More FDA Info for this Device
510(K) Number
K140039
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
AUROLAB
NO 1, SIVAGANGAI MAIN ROAD
VEERAPANJAN
MADURAI, TAMILNADU 625020 IN
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Contact
KRISHNA KUMAR.R
Other 510(k) Applications for this Contact
Regulation Number
878.4493
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Classification Product Code
GAM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/07/2014
Decision Date
09/15/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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