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PREMIUM ONE Implant Systems

Page Type
Cleared 510(K)
510(k) Number
K172560
510(k) Type
Traditional
Applicant
Sweden & Martina S.p.A
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
12/21/2017
Days to Decision
118 days
Submission Type
Statement

PREMIUM ONE Implant Systems

Page Type
Cleared 510(K)
510(k) Number
K172560
510(k) Type
Traditional
Applicant
Sweden & Martina S.p.A
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
12/21/2017
Days to Decision
118 days
Submission Type
Statement