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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 K943722
Device Name CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS
Applicant
BAXTER HEALTHCARE CORP.
1430 WAUKEGAN RD.
MCGAW PARK,  IL  60085
Applicant Contact ROBERT E OLEWINE
Correspondent
BAXTER HEALTHCARE CORP.
1430 WAUKEGAN RD.
MCGAW PARK,  IL  60085
Correspondent Contact ROBERT E OLEWINE
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/01/1994
Decision Date 11/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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