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FDA 510(k) Application Details - K014124
Device Classification Name
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
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510(K) Number
K014124
Device Name
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Applicant
NUMED, INC.
2880 MAIN ST.
HOPKINTON, NY 12965 US
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Contact
NICHELLE R LAFLASH
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Regulation Number
870.1250
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Classification Product Code
OMZ
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More FDA Info for this Product Code
Date Received
12/17/2001
Decision Date
01/16/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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