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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
510(k) Number K041215
Device Name CRANIAL HELMET
Applicant
Otto Bock Healthcare LP
2 Carlson Pwy. Suite 100
Minneapolis,  MN  55447
Applicant Contact SHELLEY STOCKMAN
Correspondent
Otto Bock Healthcare LP
2 Carlson Pwy. Suite 100
Minneapolis,  MN  55447
Correspondent Contact SHELLEY STOCKMAN
Regulation Number882.5970
Classification Product Code
MVA  
Date Received05/10/2004
Decision Date 09/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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