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FDA 510(k) Application Details - K220681
Device Classification Name
Orthosis, Cranial
More FDA Info for this Device
510(K) Number
K220681
Device Name
Orthosis, Cranial
Applicant
Invent Medical USA, LLC
1800 Mearns Rd, Suite Y
Warminster, PA 18974 US
Other 510(k) Applications for this Company
Contact
Jiri Rosicky
Other 510(k) Applications for this Contact
Regulation Number
882.5970
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Classification Product Code
MVA
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More FDA Info for this Product Code
Date Received
03/08/2022
Decision Date
09/22/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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