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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, i.v. fluid transfer
510(k) Number K002705
Device Name EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
Applicant
BAXA CORP.
13760 EAST ARAPAHOE RD.
ENGLEWOOD,  CO  80112 -3903
Applicant Contact CARL STEINECK
Correspondent
BAXA CORP.
13760 EAST ARAPAHOE RD.
ENGLEWOOD,  CO  80112 -3903
Correspondent Contact CARL STEINECK
Regulation Number880.5440
Classification Product Code
LHI  
Subsequent Product Code
NEP  
Date Received08/30/2000
Decision Date 03/28/2001
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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