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PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121383
510(k) Type
Traditional
Applicant
MEDICAL COMPONENTS INC
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
9/5/2012
Days to Decision
120 days
Submission Type
Summary

PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121383
510(k) Type
Traditional
Applicant
MEDICAL COMPONENTS INC
Country
United States
FDA Decision
Substantially Equivalent - Kit
Decision Date
9/5/2012
Days to Decision
120 days
Submission Type
Summary