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FDA 510(k) Application Details - K020146
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyamide
More FDA Info for this Device
510(K) Number
K020146
Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Applicant
SERRAL, S.A. DE C.V.
5251-18 JOHN TYLER HWY,
SUITE 167
WILLIAMSBURG, VA 23185 US
Other 510(k) Applications for this Company
Contact
SCOTT HENDERSON
Other 510(k) Applications for this Contact
Regulation Number
878.5020
More FDA Info for this Regulation Number
Classification Product Code
GAR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/16/2002
Decision Date
04/15/2002
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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