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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K930217
Device Name BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
Applicant
BAXTER HEALTHCARE CORP.
27200 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
Applicant Contact JAN ROBERTSON
Correspondent
BAXTER HEALTHCARE CORP.
27200 NORTH TOURNEY RD.
P.O. BOX 5900
VALENCIA,  CA  91355 -8900
Correspondent Contact JAN ROBERTSON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/15/1993
Decision Date 02/28/1994
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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