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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K003193
Device Name DUPLOGRIP
Applicant
BAXTER HEALTHCARE CORP.
550 NORTH BRAND BLVD.
GLENDALE,  CA  91023
Applicant Contact ARLENE VIDOR
Correspondent
BAXTER HEALTHCARE CORP.
550 NORTH BRAND BLVD.
GLENDALE,  CA  91023
Correspondent Contact ARLENE VIDOR
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/12/2000
Decision Date 11/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
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