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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K964844
Device Name CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS
Applicant
CONMED CORP.
310 BROAD ST.
UTICA,  NY  13501 -1203
Applicant Contact IRA D DUESLER, JR.
Correspondent
CONMED CORP.
310 BROAD ST.
UTICA,  NY  13501 -1203
Correspondent Contact IRA D DUESLER, JR.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/03/1996
Decision Date 03/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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