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PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082267
510(k) Type
Special
Applicant
SMITH & NEPHEW, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/29/2008
Days to Decision
79 days
Submission Type
Summary

PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082267
510(k) Type
Special
Applicant
SMITH & NEPHEW, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/29/2008
Days to Decision
79 days
Submission Type
Summary