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FDA 510(k) Application Details - K001167
Device Classification Name
Orthosis, Cranial
More FDA Info for this Device
510(K) Number
K001167
Device Name
Orthosis, Cranial
Applicant
ORTHOMERICA PRODUCTS, INC.
1001 PENNSYLVANIA AVE. NW.
6TH FLOOR
WASHINGTON, DC 20004 US
Other 510(k) Applications for this Company
Contact
WILLIAM H.E. VON OEHSEN
Other 510(k) Applications for this Contact
Regulation Number
882.5970
More FDA Info for this Regulation Number
Classification Product Code
MVA
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More FDA Info for this Product Code
Date Received
04/10/2000
Decision Date
07/07/2000
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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