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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 K014012
Device Name DOC BAND
Applicant
Cranial Technologies, Inc.
1395 W. Auto Dr.
Tempe,  AZ  85284
Applicant Contact TIMOTHY R LITTLEFIELD
Correspondent
Cranial Technologies, Inc.
1395 W. Auto Dr.
Tempe,  AZ  85284
Correspondent Contact TIMOTHY R LITTLEFIELD
Regulation Number882.5970
Classification Product Code
OAN  
Date Received12/05/2001
Decision Date 01/28/2002
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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