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FDA 510(k) Application Details - K000861
Device Classification Name
Orthosis, Cranial
More FDA Info for this Device
510(K) Number
K000861
Device Name
Orthosis, Cranial
Applicant
GILLETTE CHILDREN'S SPECIALTY HEALTHCARE
1785 GOLD COURT
EAGAN, MN 55122 US
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Contact
LINDA VALERI
Other 510(k) Applications for this Contact
Regulation Number
882.5970
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Classification Product Code
MVA
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More FDA Info for this Product Code
Date Received
03/17/2000
Decision Date
10/30/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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