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PREMIUM Implant Systems SHELTA Implant Systems

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162004
510(k) Type
Special
Applicant
SWEDEN & MARTINA S.p.A.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
12/5/2016
Days to Decision
138 days
Submission Type
Statement

PREMIUM Implant Systems SHELTA Implant Systems

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162004
510(k) Type
Special
Applicant
SWEDEN & MARTINA S.p.A.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
12/5/2016
Days to Decision
138 days
Submission Type
Statement