OSSDSIGN Cranioplug— 510(k) K181539

Substantially Equivalent

Ossdsign AB

FDA 510(k) clearance K181539 for OSSDSIGN Cranioplug, Substantially Equivalent on 2018-10-12. Applicant: Ossdsign AB.

Clearance details

Applicant: Ossdsign AB
Product code: Code GXR
Advisory panel: Neurology
Date received: 2018-06-11
Decision date: 2018-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

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