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CAPIOX RX HARDSHELL RESERVOIR

Page Type
Cleared 510(K)
510(k) Number
K013526
510(k) Type
Special
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2001
Days to Decision
23 days
Submission Type
Summary

CAPIOX RX HARDSHELL RESERVOIR

Page Type
Cleared 510(K)
510(k) Number
K013526
510(k) Type
Special
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2001
Days to Decision
23 days
Submission Type
Summary