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DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093112
510(k) Type
Traditional
Applicant
COLOPLAST MANUFACTURING US, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/1/2010
Days to Decision
123 days
Submission Type
Summary

DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093112
510(k) Type
Traditional
Applicant
COLOPLAST MANUFACTURING US, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/1/2010
Days to Decision
123 days
Submission Type
Summary