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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 K012007
Device Name RHS HELMET
Applicant
RESTORATIVE HEALTH SVS, INC.
1301 K STREET, N.W.
SUITE 1100-EAST TOWER
WASHINGTON,  DC  20005 -3373
Applicant Contact DAVID J BLOCH
Correspondent
RESTORATIVE HEALTH SVS, INC.
1301 K STREET, N.W.
SUITE 1100-EAST TOWER
WASHINGTON,  DC  20005 -3373
Correspondent Contact DAVID J BLOCH
Regulation Number882.5970
Classification Product Code
MVA  
Date Received06/27/2001
Decision Date 09/19/2001
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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