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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K933506
Device Name SYRINGE INFUSER
Applicant
BAXA CORP.
13760 EAST ARAPAHOE RD.
ENGLEWOOD,  CO  80112 -3903
Applicant Contact JEFF BALDWIN
Correspondent
BAXA CORP.
13760 EAST ARAPAHOE RD.
ENGLEWOOD,  CO  80112 -3903
Correspondent Contact JEFF BALDWIN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/20/1993
Decision Date 02/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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