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Koros USA, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
4
Inspections
5
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K120590
DILATOR TUBE SET
May 7, 2013
K101609
SELF RETAINING SOFT TISSUE RETRACTOR
December 9, 2010
K082399
PECTUS STRUT
November 5, 2009
K071338
FLEX ARM RETRACTOR SYSTEM
May 29, 2007