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FDA 510(k) Application Details - K011350
Device Classification Name
Orthosis, Cranial, Laser Scan
More FDA Info for this Device
510(K) Number
K011350
Device Name
Orthosis, Cranial, Laser Scan
Applicant
ORTHOMERICA PRODUCTS, INC.
1001 PENNSYLVANIA AVE.
6TH FLOOR
WASHINGTON, DC 20004 US
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Contact
WILLIAM H VON OEHSEN
Other 510(k) Applications for this Contact
Regulation Number
882.5970
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Classification Product Code
OAN
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More FDA Info for this Product Code
Date Received
05/02/2001
Decision Date
07/03/2001
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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