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SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011403
510(k) Type
Traditional
Applicant
ORTHOGEN CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/2001
Days to Decision
127 days
Submission Type
Summary

SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011403
510(k) Type
Traditional
Applicant
ORTHOGEN CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/11/2001
Days to Decision
127 days
Submission Type
Summary