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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 K042385
Device Name DOC BAND-POSTOP
Applicant
CRANIAL TECHNOLOGIES, INC.
1395 WEST AUTO DR.
TEMPE,  AZ  85284
Applicant Contact TIMOTHY R LITTLEFIELD
Correspondent
CRANIAL TECHNOLOGIES, INC.
1395 WEST AUTO DR.
TEMPE,  AZ  85284
Correspondent Contact TIMOTHY R LITTLEFIELD
Regulation Number882.5970
Classification Product Code
MVA  
Date Received09/01/2004
Decision Date 12/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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