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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 K933390
Device Name REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG
Applicant
PHARMACIA DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact DAVID H SHORT
Correspondent
PHARMACIA DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact DAVID H SHORT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/12/1993
Decision Date 02/09/1994
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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