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FDA 510(k) Application Details - K081002
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
More FDA Info for this Device
510(K) Number
K081002
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
SUTURES INDIA PVT., LTD.
472 D, 13TH CROSS, 4TH PHASE
PEENYA INDUSTRIAL AREA
BANGALORE 560058 IN
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Contact
L.G. CHANDRASEKHAR
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
04/08/2008
Decision Date
06/09/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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