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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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