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CUSTOM CRANIOFACIAL IMPLANT (CCI)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121755
510(k) Type
Traditional
Applicant
KELYNIAM GLOBAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/2012
Days to Decision
102 days
Submission Type
Summary

CUSTOM CRANIOFACIAL IMPLANT (CCI)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121755
510(k) Type
Traditional
Applicant
KELYNIAM GLOBAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/2012
Days to Decision
102 days
Submission Type
Summary