Device Classification Name |
Cover, Burr Hole
|
510(k) Number |
K181539 |
Device Name |
OSSDSIGN Cranioplug |
Applicant |
OssDsign AB |
Virdings Alle 2 |
Uppsala,
SE
SE 754 50
|
|
Applicant Contact |
Ulrik Birgersson |
Correspondent |
Weissburg Associates |
808 Williamson St., Suite 402 |
Madison,
WI
53703
|
|
Correspondent Contact |
David Weissburg |
Regulation Number | 882.5250
|
Classification Product Code |
|
Date Received | 06/11/2018 |
Decision Date | 10/12/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|