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FDA 510(k) Application Details - K973417
Device Classification Name
Component, Cast
More FDA Info for this Device
510(K) Number
K973417
Device Name
Component, Cast
Applicant
CLINITEX MEDICAL CORP.
9801 KINCEY AVE., SUITE 100
HUNTERSVILLE, NC 28078 US
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Contact
HOWELL H MICHAEL
Other 510(k) Applications for this Contact
Regulation Number
888.5940
More FDA Info for this Regulation Number
Classification Product Code
LGF
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More FDA Info for this Product Code
Date Received
09/10/1997
Decision Date
12/09/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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