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FDA 510(k) Application Details - K020902
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyethylene
More FDA Info for this Device
510(K) Number
K020902
Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant
SERRAL, S.A. DE C.V.
5251-18 JOHN TYLER HWY,
SUITE 167
WILLIAMSBURG, VA 23185 US
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Contact
SCOTT HENDERSON
Other 510(k) Applications for this Contact
Regulation Number
878.5000
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Classification Product Code
GAT
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More FDA Info for this Product Code
Date Received
03/20/2002
Decision Date
05/20/2002
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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