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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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