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FDA 510(k) Application Details - K992539
Device Classification Name
Finger Cot
More FDA Info for this Device
510(K) Number
K992539
Device Name
Finger Cot
Applicant
DIGIT-PRO
10555 WEST LITTLE YORK RD.
HOUSTON, TX 77041 US
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Contact
KEVIN SORRELS
Other 510(k) Applications for this Contact
Regulation Number
880.6250
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Classification Product Code
LZB
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More FDA Info for this Product Code
Date Received
07/30/1999
Decision Date
02/18/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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