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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, cranial, laser scan
510(k) Number K011350
Device Name STARBAND CRANIAL ORTHOSIS
Applicant
ORTHOMERICA PRODUCTS, INC.
1001 PENNSYLVANIA AVE.
6TH FLOOR
WASHINGTON,  DC  20004
Applicant Contact WILLIAM H VON OEHSEN
Correspondent
ORTHOMERICA PRODUCTS, INC.
1001 PENNSYLVANIA AVE.
6TH FLOOR
WASHINGTON,  DC  20004
Correspondent Contact WILLIAM H VON OEHSEN
Regulation Number882.5970
Classification Product Code
OAN  
Date Received05/02/2001
Decision Date 07/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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