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SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042359
510(k) Type
Traditional
Applicant
MEDICAL DESIGNS, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/17/2004
Days to Decision
78 days
Submission Type
Summary

SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042359
510(k) Type
Traditional
Applicant
MEDICAL DESIGNS, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/17/2004
Days to Decision
78 days
Submission Type
Summary