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PREMIUM - SHELTA Prosthetic Components

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162028
510(k) Type
Traditional
Applicant
SWEDEN & MARTINA S.p.A.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
3/24/2017
Days to Decision
245 days
Submission Type
Statement

PREMIUM - SHELTA Prosthetic Components

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162028
510(k) Type
Traditional
Applicant
SWEDEN & MARTINA S.p.A.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
3/24/2017
Days to Decision
245 days
Submission Type
Statement