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FDA 510(k) Application Details - K993052
Device Classification Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
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510(K) Number
K993052
Device Name
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days
Applicant
VYGON CORP.
1129 BLOOMFIELD AVE.
WEST CALDWELL, NJ 07006 US
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Contact
ROBERT SCHIFF
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Regulation Number
880.5970
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Classification Product Code
LJS
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More FDA Info for this Product Code
Date Received
09/13/1999
Decision Date
08/03/2000
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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