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CAMLAB CRANIAL ORTHOSIS HELMET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081787
510(k) Type
Traditional
Applicant
BIOSCULPTOR CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/27/2009
Days to Decision
217 days
Submission Type
Summary

CAMLAB CRANIAL ORTHOSIS HELMET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081787
510(k) Type
Traditional
Applicant
BIOSCULPTOR CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/27/2009
Days to Decision
217 days
Submission Type
Summary