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FDA 510(k) Application Details - K081366
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyamide
More FDA Info for this Device
510(K) Number
K081366
Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Applicant
NASHVILLE SURGICAL INSTRUMENTS
2005 KUMAR LANE
SPRINGFIELD, TN 37172 US
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Contact
SARBJEET KUMAR
Other 510(k) Applications for this Contact
Regulation Number
878.5020
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Classification Product Code
GAR
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More FDA Info for this Product Code
Date Received
05/15/2008
Decision Date
07/15/2008
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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