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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 K000861
Device Name CRANIOCAP
Applicant
GILLETTE CHILDREN'S SPECIALTY HEALTHCARE
1785 GOLD COURT
EAGAN,  MN  55122
Applicant Contact LINDA VALERI
Correspondent
GILLETTE CHILDREN'S SPECIALTY HEALTHCARE
1785 GOLD COURT
EAGAN,  MN  55122
Correspondent Contact LINDA VALERI
Regulation Number882.5970
Classification Product Code
MVA  
Date Received03/17/2000
Decision Date 10/30/2000
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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