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CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING

Page Type
Cleared 510(K)
510(k) Number
K061527
510(k) Type
Special
Applicant
SORIN GROUP ITALIA S.R.L.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/27/2006
Days to Decision
25 days
Submission Type
Summary

CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING

Page Type
Cleared 510(K)
510(k) Number
K061527
510(k) Type
Special
Applicant
SORIN GROUP ITALIA S.R.L.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/27/2006
Days to Decision
25 days
Submission Type
Summary