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CRANIAL REMOLDING ORTHOSIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111247
510(k) Type
Traditional
Applicant
ORTHOTIC CARE SERVICES, LLP
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/15/2011
Days to Decision
104 days
Submission Type
Summary

CRANIAL REMOLDING ORTHOSIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111247
510(k) Type
Traditional
Applicant
ORTHOTIC CARE SERVICES, LLP
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/15/2011
Days to Decision
104 days
Submission Type
Summary